Fibromyalgia Clinical Trial
Official title:
A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
NCT number | NCT01693692 |
Other study ID # | 0092 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | April 2014 |
Verified date | February 2022 |
Source | Theravance Biopharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
Status | Completed |
Enrollment | 392 |
Est. completion date | April 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM) - Informed consent - 18 to 65 years of age - Discontinue therapy with adrenergic-acting drugs, and certain other medications - Only acetaminophen or NSAID as rescue pain medication - No narcotic pain meds or benzodiazepines - Only non-benzodiazepines as rescue hypnotics Exclusion Criteria: - Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI) - Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment) - Risk of suicide (investigator opinion and/or C-SSRS) - Recent history of substance or alcohol abuse - BMI <18 or =45 - Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea - Abnormal lab values (liver, kidney, thyroid, and others) |
Country | Name | City | State |
---|---|---|---|
United States | Florida Clinical Research Center, LLC | Bradenton | Florida |
United States | PAB Clinical Research | Brandon | Florida |
United States | Beacon Clinical Research | Brockton | Massachusetts |
United States | ClinSearch, LLC | Chattanooga | Tennessee |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Meridian Clinical Research | Dakota Dunes | South Dakota |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | TriWest Research Associates, LLC | El Cajon | California |
United States | MediSphere Medical Research Center, LLC | Evansville | Indiana |
United States | Lillestol Research, LLC | Fargo | North Dakota |
United States | Dedicated Clinical Research | Goodyear | Arizona |
United States | Clinical Investigation Specialists, Inc. | Gurnee | Illinois |
United States | Rheumatology Associates of North Alabama, PC | Huntsville | Alabama |
United States | The Center for Pharmaceutical Research | Kansas City | Missouri |
United States | Meridien Research | Lakeland | Florida |
United States | Advanced Biomedical Research of America | Las Vegas | Nevada |
United States | Sunstone Medical Research, LLC | Medford | Oregon |
United States | Coastal Carolina Research Center | Mount Pleasant | South Carolina |
United States | Beacon Clinical Research | New Bedford | Massachusetts |
United States | Coastal Connecticut Research, LLC | New London | Connecticut |
United States | Renstar Medical Research | Ocala | Florida |
United States | Meridian Clinical Research | Omaha | Nebraska |
United States | Compass Research, LLC | Orlando | Florida |
United States | Clinical Research Source, Inc. | Perrysburg | Ohio |
United States | Arroyo Medical Group, Inc. | Pismo Beach | California |
United States | Wake Research Associates | Raleigh | North Carolina |
United States | Carolina Center for Rheumatology & Arthritis Care | Rock Hill | South Carolina |
United States | Swedish Rheumatology Research | Seattle | Washington |
United States | GTC Research | Shawnee Mission | Kansas |
United States | Tulsa Clinical Research, LLC | Tulsa | Oklahoma |
United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
United States | Omega Medical Research | Warwick | Rhode Island |
United States | Upstate Clinical Research Associates, LLC | Williamsville | New York |
United States | The Center for Clinical Research | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Theravance Biopharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries | Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain. | Baseline and Week 6 | |
Secondary | Fibromyalgia Impact Questionnaire (FIQ) | FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia. | Day 43 (End of study treatment) | |
Secondary | Patient Global Impression of Change (PGIC) | PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse. | Day 43 (End of study treatment) |
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