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Phase 2 Study of TD-9855 to Treat Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693692
First Posted: September 26, 2012
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
September 20, 2012
September 26, 2012
September 9, 2014
November 2012
January 2014   (Final data collection date for primary outcome measure)
Percent change in mean pain score based on the mean of the last 7 daily pain NRS scores from the daily pain diaries [ Time Frame: Up to 9 weeks ]
Change in Pain Numerical Rating Scale [ Time Frame: Between baseline (Day 1) and study drug completion (Day 43) ]
Complete list of historical versions of study NCT01693692 on ClinicalTrials.gov Archive Site
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: From Run-In through End of Study (Day 63) ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: From Baseline through End of Study (Day 63) ]
  • Change in the Patient Global Impression of Change [ Time Frame: Between baseline (Day 1) and study drug completion (Day 43) ]
  • Change in the Fibromyalgia Impact Questionnaire score [ Time Frame: Between baseline (Day 1) and study drug completion (Day 43) ]
Not Provided
Not Provided
 
Phase 2 Study of TD-9855 to Treat Fibromyalgia
A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: TD-9855 Group 1
  • Drug: TD-9855 Group 2
  • Drug: Placebo
  • Experimental: TD-9855 Group 1
    Group 1 to be dosed with TD-9855
    Intervention: Drug: TD-9855 Group 1
  • Experimental: TD-9855 Group 2
    Group 2 to be dosed with TD-9855
    Intervention: Drug: TD-9855 Group 2
  • Placebo Comparator: Placebo
    Group to be dosed with Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
April 2014
January 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01693692
0092
No
Not Provided
Not Provided
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
Theravance Biopharma R & D, Inc.
Not Provided
Not Provided
Theravance Biopharma Antibiotics, Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP