COMPLEX REGIONAL PAIN SYNDROME. Informed Consent Overview

Transcription

1 COMPLEX REGIONAL PAIN SYNDROME Informed Consent Overview

2 About clinical research Clinical research studies, also called trials, are carried out to learn or add knowledge about the effects and safety of drugs. These drugs are not yet registered or are used to treat other diseases. Trials are subject to strict laws and regulations, international guidelines, and ethical guidelines. This trial, like other trials, has been reviewed by an independent authority and an ethics committee. 2

3 Why is this clinical trial being done? The purpose of this trial is to evaluate the safety of neridronic acid in patients with complex regional pain syndrome (CRPS). Its effectiveness in reducing pain due to CRPS and its effect on your ability to perform daily activities, quality of life, and other outcomes will also be studied. Another purpose of this trial is to measure levels of markers in your blood that indicate changes in your bones. 3

4 This study and you Approximately 220 patients globally who have CRPS will be included in this trial. You may qualify for this study if you: Are at least 18 years of age Have been diagnosed with CRPS Have been receiving treatment for CRPS for at least one month Additional requirements apply. During this trial, the study drug and all study-related care will be provided to you at no cost. 4

5 How long will I be in the study? You will be in the trial for approximately 14 months. The trial has three periods: Enrollment period Up to 60 days before the treatment period begins, the study doctor will ask you about your medical history and perform a series of tests, including a physical exam and taking blood and urine samples, to make sure you qualify. Treatment period You will be given the study medication at the study clinic four times over 10 days. The study medication will be given by intravenous (IV) infusion over approximately four hours. Each of these visits may last up to about eight hours. Follow-up period Additional medical evaluations will take place to see how you are feeling. You will visit the study clinic six times over approximately 50 weeks. These visits will last about two to three hours. Additional visits may be scheduled if necessary. 5

6 What will happen during the study? The study doctor or a study staff member will perform the following procedures: Blood tests: Blood will be taken from you for routine tests and for levels of markers in your blood. Urine tests: Your urine will be tested for ph, protein, etc., as well as for the presence of drugs, and if you are a woman who can have children, it will be checked for pregnancy. Electrocardiogram: This test records heart rhythms to measure the electrical activity of your heart using electrodes placed on your chest, arms, and legs. 6

7 What will happen during the study? (Cont.) Continuous electrocardiogram monitoring: During the infusion visits, you will be connected to a device that continuously monitors the electrical activity of your heart. General checkups: Your trial doctor will measure your weight, blood pressure, pulse rate, and breathing rate at every visit and will perform a physical exam at certain visits. You will be regularly asked how you are feeling and about any symptoms or complaints you may have. Pain rating: At each visit you will be asked to rate your pain using an electronic tablet device. Questionnaires about how you are doing: If you are participating in a U.S. study site, you will complete questionnaires about your pain and answer questions about your functioning and well-being at different visits during the trial. 7

8 About the study drug Neridronic acid belongs to a family of drugs known as bisphosphonates, which have been used to treat a variety of diseases for at least 40 years. Treatment with neridronic acid in a previous clinical trial reported significant reductions in pain and other symptoms associated with CRPS. You will receive four infusions of the trial medication in a vein on Day 1, Day 4, Day 7, and Day 10. 8

9 About informed consent If you qualify and agree to be part of this trial, you will read and sign an informed consent document, stating that the study has been explained to you, your questions have been answered, and you agree to participate. The informed consent document is not a contract, and you may withdraw from the study for any reason at any time. 9

10 What do I have to do during the trial? During the trial, you are asked to adhere to the following: Follow the instructions you are given by your trial doctor. Come to the trial site for visits with the trial doctor. Tell the trial doctor or trial staff about any changes in your health. Inform your trial doctor if you take any new medications or change the amount or frequency of medications you are taking during the trial. Carry with you at all times the trial card that identifies you as a trial participant. 10

11 What do I have to do during the trial? (Cont.) Do not take any other medications, vitamins, or alternative therapies (herbal remedies) during the trial that have not been discussed with your trial doctor. You must take calcium and vitamin D supplements provided by the study staff. Do not use other kinds of treatments for CRPS, such as acupuncture and nerve blocks, or make changes to any allowed treatment for CRPS, such as spinal cord stimulation. Do not use substances like cocaine, ecstasy, or amphetamines. Do not take part in another clinical trial from three months prior to the start of this trial until completion. Brush your teeth, floss, and see your dentist as recommended. 11

12 What do I have to do during the trial? (Cont.) You must inform and consult with your clinical trial doctor before consulting with another doctor or undergoing any other medical treatment. This rule does not apply if there is a medical emergency, but your trial doctor has to be informed immediately if you receive any emergency treatment. If for any reason you consult with another doctor during the trial, you must tell the doctor that you are taking part in a clinical trial and show him/her your trial card. This may be important for diagnosing and treating your complaints. You must tell your trial doctor immediately if anything affecting your health occurs that may have something to do with the trial medication. 12

13 Learning more More information about this trial is available online at: [contact information] 13