Please carefully read the consent form
Helene Bertrand, M.D. North Vancouver, B.C., Canada
Research subject information and Consent form
Mannitol Cream in the Treatment of Post-herpetic Neuralgia; a Randomized Placebo-Controlled Crossover Pilot Study
This consent form contains important information to help you decide whether to
participate in a research study.
The study staff will explain this study to you. Ask questions about anything that is not clear at any time. You may take home an unsigned copy of this consent form to think about and discuss with family or friends.
Ø Being in a study is voluntary – your choice.
Ø If you join this study, you can still stop at any time.
Ø No one can promise that a study will help you.
Ø Do not join this study unless all of your questions are answered.
After reading and discussing the information in this consent form you should know:
· Why this research study is being done;
· What will happen during the study;
· Any possible benefits to you;
· The possible risks to you;
· Other options you could choose instead of being in this study;
· How your personal health information will be treated during the study and after the study is over;
· Whether being in this study could involve any cost to you; and
· What to do if you have problems or questions about this study.
Please read this consent form carefully.
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
Title: Mannitol Cream in the Treatment of Post-herpetic Neuralgia; a Randomized Placebo-Controlled Crossover Pilot Study
Protocol No.: H15-01260
Sponsor: Helene Bertrand, M.D.
North Vancouver, British Columbia
- Helene Bertrand, M.D.
220-1940 Lonsdale Avenue.
North Vancouver, B.C. V7M 2K2
- K. Dean Reeves, MD
Clinical Associate Professor
University of Kansas Department of Physical Medicine and Rehabilitation.
- Marylene Kyriazis Pharm.D.
Clinical instructor, University of British Columbia,
Faculty of Pharmaceutical Sciences
- Tess Debelle
3rd Year Medical Student
Gronigen University, Holland
- Jessy Urzen
School of medicine, University of Louisville, Kentucky
- Ria Dhannellie-Garlejo
Dr. Bertrand’s medical office assistant
Site(s): North Vancouver, Dr. Bertrand’s office
PHONE NUMBER(S): Helene Bertrand, M.D.
This consent form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.
You are invited to be in a research study. The purpose of this consent form is to help you decide if you want to be in the research study. Please read this form carefully. To be in a research study you must give your informed consent. "Informed consent" includes:
· Reading this consent form
· Having the study doctor or staff explain the research study to you
· Asking questions about anything that is not clear
· Reviewing this consent form in advance. It has been provided on-line for pre-viewing at www.QRcream.com.
You should not join this research study until all of your questions are answered to your satisfaction.
Things to know before deciding to take part in a research study:
· Taking part in a research study is voluntary. No one can make you take part.
· The decision to join or not join the research study will not cause you to lose any medical benefits.
· The main goal of a research study is to learn things to help others in the future.
· The main goal of regular medical care is to help the person receiving that care.
PURPOSE OF THE STUDY
This study is a pilot project to see if mannitol cream will reduce the pain you feel more than control cream. A “pilot study” is done to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. This type of study involves a small number of participants and so it is not expected to prove safety or effectiveness. The information we gather from this study will be used to determine how many people with post-herpetic neuralgia need to be enrolled to get a statistically significant result in a larger study. If there is a marked difference between the two types of cream, which is statistically significant, the results of this study will be published.
Mannitol cream application has shown apparent benefit is acute and chronic pain conditions. We tried this cream on 4 people with severe pain after shingles (post-herpetic neuralgia) and found that it gave them relief from their pain. This is the first formal clinical trial of mannitol as an active ingredient in a cream for pain control. Therefore, mannitol cream use at this time is considered investigational (experimental).
Health Canada has not approved the sale or use of 30% mannitol cream to treat post-herpetic neuralgia, although they have allowed its use in this clinical study, and have approved its sale, when combined with menthol, for the temporary relief of muscle aches and pains.
A major goal of this study is to learn if this cream can help people with severe nerve pain in the future. These things include:
· Giving those who suffer from nerve pain a new way to deal with the pain.
· If this cream does reduce this pain, we will try it for other kinds of pain, such as the pain of arthritis or migraine headaches or the burning pain people get from diabetes.
WHO can participate?
You can take part in this study if you are
- Older than 19 years of age
- Suffering from post-herpetic neuralgia (pain after shingles) on the trunk or the extremities for at least three months.
- Your maximum daily pain score is greater than or equal to 5/10 (where 0/10 = no pain and 10/10 = the worst pain imaginable).
- Have failed to improve with at least one medication for nerve pain.
- Are able and willing to fill a pain scale and a medication intake questionnaire daily, preferably online but on paper, if unable, for the first 24 days of the study, then once a month for three months, then at six months and one year.
- You preferably have access to someone who can apply cream to your back if you have pain in the back and cannot reach the area.
- If that is not possible, you would be able to apply the cream to your own back, using an applicator which will be supplied.
WHO SHOULD NOT PARTICIPATE?
You should not take part in this study if you have
- Neuralgia pain involving your neck, your head, or your face
- Allergies to any of the ingredients of the cream, or eye liner we will be using in this study. (Before we invite you to participate in this study, we will be testing you for this)
- Open lesions or abrasions on the skin where the cream will be applied.
- Are using corticosteroids
- Are unwilling to stop using other topical products (creams or patches) for the treatment of your post-herpetic neuralgia pain
- Are pregnant
- Are suffering from severe chronic pain from a cause other than post-herpetic neuralgia
If you qualify to be in this study, you will be asked to sign and date this consent form. You will receive a copy of this form.
If you choose to be in the study, you may still apply usual self-treatment measures for “helping you deal with your pain” such as rest, extra sleep, well balanced diet, cool compresses and your usual medication. You will be asked to keep a record of how much of your medication and alcohol you use. Just tell us how many and what pills you needed and how many drinks you had.
Please, however, avoid all creams, as we will be unable to judge this cream if you use other creams for pain.
We anticipate that 12 people with post-herpetic neuralgia (pain after shingles) will participate in the study. Your participation in the first part of this study will last for 24 days. After that, you will be given a supply of the active mannitol cream to help relieve your pain.
As part of the study, there will be:
- A 7 day observation period where you will record your pain and how much medication and alcohol you need to take every day using an email with a survey link email with a survey link or a paper questionnaire, if you have no access to computers.
- A 7 day test period, where you will apply cream as needed where you have pain and will report on your pain and medication and alcohol intake, as well as the effects of the cream, using the email with a survey link or the paper questionnaire.
- During the test week, you will receive either mannitol cream or a cream without the mannitol, a placebo: (an inactive substance that looks identical to the test drug/intervention). These creams have similar appearance, and feel. You will be reminded by email to fill out the form once a day. If you do not fill out the form online, we will telephone you the following morning to obtain your data.
- The data consists of questions on how much pain you have in the area where you had the shingles, medication use, alcohol intake and how many times you applied the cream, the effects and potential side effects of the cream.
- After that seven day test period, there will be a 3 day “washout” period where you will not apply any cream but will keep tabs on your pain and medication and alcohol intake.
- When you come back after that washout period there will be another 7 day test period where you will get the other cream to apply where you have pain and keep recording your pain scores, your medication and alcohol intake, how often you apply the cream and whether you get effects or side effects from the cream.
- Whether you receive the mannitol cream in the first 7 day period or in the second 7 day period will be randomly assigned. Random assignment means by chance (like the flip of a coin).
- It is very important that you try both creams and fill out these questionnaires every day as this is how we will be able to see which of the 2 creams is most effective in helping relieve the pain you feel.
- After this 24 day “test” period, you will receive one month’s supply of the mannitol cream.
- At the end of this month you will answer the email with a survey link or paper questionnaire the day before you come back to the office, where you will be re-examined. When you come, we will give you another month’s supply of the cream.
- This will be done once more, so that you will have as much cream as you need for three months. That way we will learn whether you keep getting better as you use the cream.
- If you become pain-free for more than three days before the end of the three months, we will ask you to note the last day of your pain and to bring back your cream.
- If your pain comes back or is still there after the three month period, let us know and we will give you more cream to apply for the next 9 months.
- Six months and one year after you start using the cream, we will send you an email with a survey link or we will phone you to find out how you are doing.
In total, you will be participating in this study for one year and 24 days. If you use the cream for the 1st 3 months, you will need about 18 ½ hours to apply the cream and answer the questionnaires. You will need more time to apply the cream if you continue to apply the cream for the last 9 months. A table summarizing everything that will happen can be found on the QRcream website. If you do not have access to a computer, we have mailed it to you when we mailed you this consent form.
The data (only de-identified data) we collect from your participation in this study will be used to plan a larger study and for purposes of publication.
Your participation in this study is important so that this cream, if it proves effective, can be made available to others who are suffering.
As you get pain relief, you will need to cut down on your pain medications very slowly. Please ask your family physician to monitor this. You can also get help from our pharmacist, Dr. Marylene Kyriazis.
RISKS AND DISCOMFORTS
Cream Application Risks
Mannitol cream has been used on 243 people, there have been no side effects and most got pain relief. The risks of cream application of the type used in this study include the following:
- Allergy: the creams used in both the mannitol cream and the control cream are both identical and hypoallergenic. Mannitol, a sugar derivative, is a component of many creams and is not as a rule associated with allergy. We will ask those with a strong allergy history to observe for reactions.
- Tell your doctor if you have
- any rash or significant itching or
- any wheezing
- or other suspect allergic reaction.
In case you get a rash where you applied the cream, stop using the cream and contact Dr. Bertrand. You will be withdrawn from the study and she will prescribe you a cream containing cortisone NPN 02243847.
Women who are pregnant or nursing a child will be excluded from this study although there is no reason to expect any excess risk.
People with open lesions or abrasions on their skin where the cream will be applied, will also be excluded, as the cream may produce a burning sensation when it is applied on open wounds.
Your condition may not get better or may get worse during this study. There may also be risks or side effects that are unknown at this time.
WHAT IF SOMETHING GOES WRONG?
By signing this form, you do not give up any of your legal rights and you do not release the study doctor, participating institutions, or anyone else from their legal and professional duties. If you become ill or physically injured as a result of participation in this study, medical treatment will be provided at no additional cost to you. The costs of your medical treatment will be paid by your provincial medical plan.
You will be told about any new information that might change your decision to be in this study. You may be asked to sign a new consent form if this occurs.
Your pain may improve faster if you are using the mannitol cream rather than the control cream; however, this cannot be promised. The results of this study may help people with pain after shingles in the future. There is no guarantee that you will receive any medical benefits from being in this study. Your pain may not be altered by this cream.
If the simple cream application method used in the study is effective in reducing pain faster, it will help to stimulate further research and may change our understanding of why people have pain after shingles.
COMPENSATION FOR INJURY
If you are injured or get sick as a result of being in this study, call the study doctor immediately. The study doctor will direct you to appropriate emergency medical treatment.
By signing this consent form, you will not waive any of your legal rights.
If you choose not to be in the study, you may still apply usual self-treatment measures for optimizing recovery such as rest, extra sleep, well balanced diet, cool compresses. Alternative treatments also include anti-inflammatory medication and pain killers. Please consult your family physician for treatment.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary. You may decide not to participate or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled. You may withdraw from this study at any time without giving reasons. If you choose to enter the study and then decide to withdraw at a later time, all information about you, collected up to the point of your withdrawal, will be retained for analysis in order to protect the integrity of the research, which may benefit future research participants and patients. However, no further information will be collected.
Your participation in this study may be stopped at any time and for any reason by the study doctor without your consent
- if it is in your best interest;
- if you do not consent to continue in the study after being told of changes in the research that may affect you.
WHO IS CONDUCTING THIS STUDY?
Dr. Helene Bertrand, M.D. and Dr. Marylene Kyriazis, Pharm.D. have invented this cream and have a patent pending on it. If the cream is proven to be effective in providing pain relief, they plan to manufacture and sell it.
SOURCE OF FUNDING FOR THE STUDY
Funding for this research study will be provided by the primary investigator or her study associates.
PAYMENT FOR PARTICIPATION
You will not be paid for being in this study.
COSTS OF PARTICIPATION
The mannitol cream will be provided to the participant at no cost. You might have unexpected expenses from being in this research study. For example, if you experience an allergic reaction medical services are to be provided as available from MSP.
Your confidentiality will be respected. However, research records and health or other source records identifying you may be inspected in the presence of Dr. Bertrand or her designate by representatives of Health Canada, and the UBC ethics committee for the purpose of monitoring the research. No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law.
You will be assigned a unique study number as a participant in this study. This number will not include any personal information that could identify you (e.g., it will not include your Personal Health Number, SIN, or your initials, etc.). Only this number will be used on any research-related information collected about you during the course of this study, so that your identity will be kept confidential. Information that contains your identity will remain only with Dr. Bertrand and/or designate. The list that matches your name to the unique study number that is used on your research-related information will not be removed or released without your consent unless required by law.
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to insure that your privacy is respected. You also have the legal right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available on request to your study doctor.
Any study related data sent outside of Canadian borders may increase the risk of disclosure of information because the laws like the Patriot Act in the United States, dealing with protection of information, may not be as strict as in Canada. However, all study related data that might be transferred outside of Canada will be coded (this means it will not contain your name or personal identifying information) before leaving the study site. By signing this consent form, you are consenting to the transfer of your information to organizations located outside of Canada:
- K. Dean Reeves, MD, University of Kansas Department of Physical Medicine and Rehabilitation.
- Tess Debelle, Faculty of Medical Sciences, Gronigen University, Holland
- Jessy Urzen, M.D., School of medicine, University of Louisville, Kentucky
The results of this research study may be presented at meetings or in publications. Your identity will not be disclosed in those presentations.
Contact Helene Bertrand, M.D., at 604-985-5381 or 778-227-7776 (cell) for any of the following reasons:
- If you have any questions about this study or your part in it,
- If you feel you have had a research-related injury or a bad reaction to the study cream,
- If you have questions, concerns, or complaints about the research.
- If your pain disappears for more than three days.
Who do I contact if I have any questions about the study during my participation?
You are encouraged to ask questions at any time during the study. In case you would experience side effects or have further questions about the study, please contact your study doctor (for contact details see page 1).
If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the University of British Columbia Office of Research Ethics by e-mail at RSIL@ors.ubc.ca or by phone at 604-822-8598604-822-8598 (Toll Free: 1-877-822-85981-877-822-8598 FREE).
Do not sign this consent form unless you have had a chance to ask questions and have gotten satisfactory answers.
You can Join the research after reading and understanding the consent form Above
You can submit your participation via the form below or you can:
bring the signed form with you, to the office.