NCT01693692CompletedPhase 2
A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Theravance Biopharma
- Enrollment
- 392
- Locations
- 32
- Primary Endpoint
- 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
Study Overview
Brief Summary
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
TD-9855 Group 1
Experimental
Group 1 to be dosed with TD-9855
Intervention: TD-9855 Group 1 (Drug)
TD-9855 Group 2
Experimental
Group 2 to be dosed with TD-9855
Intervention: TD-9855 Group 2 (Drug)
Placebo
Placebo Comparator
Group to be dosed with Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Baseline and Week 6
Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
Secondary Outcomes
- Fibromyalgia Impact Questionnaire (FIQ)(Day 43 (End of study treatment))
- Patient Global Impression of Change (PGIC)(Day 43 (End of study treatment))
Investigators
Study Sites (32)
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