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Phase 2 Study of TD-9855 to Treat Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01693692
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: TD-9855 Group 1 Drug: TD-9855 Group 2 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
Study Start Date : November 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: TD-9855 Group 1
Group 1 to be dosed with TD-9855
 Drug: TD-9855 Group 1
Experimental: TD-9855 Group 2
Group 2 to be dosed with TD-9855
 Drug: TD-9855 Group 2
Placebo Comparator: Placebo
Group to be dosed with Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: From Run-In through End of Study (Day 63) ]
  2. Patient Global Impression of Change (PGIC) [ Time Frame: From Baseline through End of Study (Day 63) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693692


  Show 34 Study Locations
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT01693692     History of Changes
Other Study ID Numbers: 0092
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases