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Follow on Google News | New Fibromyalgia (FM) Clinical Trial Now Enrolling at Avail Clinical Research in Central FloridaAvail Clinical is conducting an 11-week, Phase 2 Multicenter, Randomized, Double−Blind, Parallel−Group, Placebo−Controlled Study of a new drug in Subjects with Fibromyalgia (FM).
By: Avail Clinical Research STUDY POPULATION: Adults with fibromyalgia DURATION OF STUDY PARTICIPATION: Up to 78 days from Screening Visit through Follow-Up. BACKGROUND & RATIONALE: A brand new drug is being developed for the management of fibromyalgia (FM). Fibromyalgia is a common, chronic, widespread pain disorder that is estimated to impact 0.5% to 5% of the general population worldwide. In the United States, more than 5 million individuals are thought to be affected, and it is the second most common disorder observed by rheumatologists (after osteoarthritis (http://www.availclinical.com/ The standard of care for FM includes both non-pharmacologic (exercise, education, and cognitive-behavioral therapy) and pharmacologic approaches. In the United States, three drugs are currently approved for the treatment of fibromyalgia (http://www.availclinical.com/ OBJECTIVES: The primary objective of the study is to assess the ability of a new drug to reduce Fibromyalgia pain. The secondary objective of the study is to assess overall improvement in fibromyalgia following treatment with a new Fibro drug relative to placebo. This will be assessed by: the Patient Global Impression of Change (PGI-C); and the Fibromyalgia Impact Questionnaire (FIQ) total score. The key exploratory objective of the study is to evaluate the efficacy of a new Fibro drug, relative to placebo, on fatigue, or tiredness, as measured on: the Daily Fatigue Score: Fibromyalgia (DFS-Fibro), a self-reported outcome measure for daily use that was recently developed specifically for the FM population; and the Multidimensional Assessment of Fatigue (MAF), a weekly assessment of fatigue that has been used in other pharmaceutical trials in FM. In addition, the study includes a number of other exploratory efficacy endpoints to evaluate the effect of 5 mg and 20 mg of a new Fibro drug, relative to placebo, in subjects with FM, with respect to the following: Mood, using the Hospital Anxiety and Depression Scale (HADS); Overall health-related quality of life, using the Medical Outcomes Study Short Form 36 (SF-36) Quality of Life; Cognitive performance, using the Paced Auditory Serial Addition Test (PASAT) and the Auditory Consonant Trigram (ACT) test; Perceived cognitive difficulties, using the Multiple Ability Self-Report Questionnaire (MASQ); Executive function, using the Barkley Deficits in Executive Functioning Scale-Short Form: Self Report (BDEFS-SF: Self Report) for Adults; and Sexual function, using the Arizona Sexual Experiences Scale (ASEX) The pharmacokinetics (PK) of a new Fibro drug in subjects with fibromyalgia will also be studied using population PK methodology. INCLUSION CRITERIA 1. Subjects must possess a level and degree of understanding of spoken and written language that enables them to communicate effectively with investigator and study coordinator as well as to complete questionnaires. Subject has signed an Institutional Review Board (IRB) or Independent Ethics Committee (EC) approved Informed Consent Form. 2. Subjects must be 18 to 59 years of age, inclusive, at the time of consent. 3. At screening, subjects must meet the diagnostic criteria for FM, as defined by the 1990 ACR Criteria for the classification of fibromyalgia, including: Widespread aching pain in four quadrants of the body and axial skeleton for greater than or equal to 3 months duration. Pain is considered widespread when all of the following are present: pain on both sides of the body, pain above and below the waist. In addition, axial skeletal pain (cervical spine, anterior chest, thoracic spine, or low back pain (http://www.availclinical.com/ Pain in greater than or equal to 11 of 18 tender points under digital palpation examination with an approximate force of 4 kg/cm2. 4. Subjects must have a score of greater than or equal to 4 on the 11-point Pain-NRS (0 = no pain to 10 = worst possible pain) for pain relating to their FM at the initial Screening Visit. 5. Subject must be willing and able to comply with all the testing and requirements defined in this protocol, as well as the restrictions and directions of the investigational site staff. 6. Subjects must not initiate concomitant therapy during the course of the study and are not to have been receiving excluded medications. 7. Subjects must agree not to initiate use of sleep-promoting medications 8. Subjects must be willing to discontinue treatment with transcutaneous electrical nerve stimulation and anesthetic or narcotic patches, beginning at least 1 day before the Run-in Visit. 9. Subjects must agree to continue all pre-existing (greater than or equal to 30 days before Screening) 10. Subjects must agree to use only acetaminophen (less than or equal to 3,000 mg/day) 11. For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 12. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after study dosing. 13. Subjects who are smokers must be willing to maintain a stable smoking habit throughout the study. 14. Subjects must agree that they will not alter their regular caffeine consumption throughout the study. 15. Subjects must demonstrate compliance with completion of the daily diary for greater than or equal to 5 of 7 days per week at the end of the placebo Run-in Period. 16. Subjects must have a 1-week mean pain *Avail Clinical Research conducts Clinical Research Trials in Florida (http://www.availclinical.com/ End
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