Expired Study
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Clinical Trial 4041

Oklahoma City, OK 73119

Study Summary:

This is a 15-day, longitudinal, observational study to examine the measurement properties of the BF-Diary. The subject population will consist of approximately 525 patients, in approximately 100 sites, with chronic, non-cancer pain, who have not taken opioid therapy for treatment of their pain for at least 14 days and who do not consider themselves constipated at the start of the study. A subset of 90 of these subjects who experience onset of opioid-induced constipation (OIC) symptoms during the course of the study and complete a 14-day observation period is needed to complete analyses. Subjects will answer items on a number of assessments at regularly scheduled intervals. After screening and enrollment, all data will be entered electronically using a Personal Digital Assistant (PDA). A 14-day observation period has been chosen for two reasons: it is similar to the design of a clinical trial measuring OIC in which the BF-Diary will be used; and studies measuring the incidence OIC have used weekly increments to measure change in bowel function. Subjects will return to the site on Day 15 for final assessments and to exit the study.

Qualified Participants Must:

• Have signed an informed consent document indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial
• Be fluent in English
• Be at least 18 years of age
• Have been diagnosed with any of the following chronic pain conditions in the medical judgment of the investigator based on subject examination and history
• Lower back pain
• Osteoarthritis of the hip or knee, including OA which has progressed to: End stage joint disease
• In the medical judgment of the investigator based on subject examination and history are appropriate for, and will be prescribed, oral opioid medication for management of their chronic pain condition 4 or more days per week
• Be willing to follow clinician prescribed treatment plans which include oral opioid medication for treatment of their chronic pain condition
• Be willing to complete all the required assessments on the electronic diary device (PDA) and return for study visits as scheduled during the entire study period
• Opioid naïve or no opioid treatment within 14 days of baseline visit

Qualified Participants May Receive:

You will receive $200 for taking part in this study, $100 per completed visit.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.