Phase 2 Study of TD-9855 to Treat Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier:
NCT01693692
First received: September 20, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.


Condition Intervention Phase
Fibromyalgia
Drug: TD-9855 Group 1
Drug: TD-9855 Group 2
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: From Run-In through End of Study (Day 63) ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: From Baseline through End of Study (Day 63) ] [ Designated as safety issue: No ]

Enrollment: 392
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693692

  Hide Study Locations
Locations
United States, Alabama
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States, 35801
United States, Arizona
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
United States, California
TriWest Research Associates, LLC
El Cajon, California, United States, 92020
Arroyo Medical Group, Inc.
Pismo Beach, California, United States, 93449
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Connecticut
Coastal Connecticut Research, LLC
New London, Connecticut, United States, 06320
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201
PAB Clinical Research
Brandon, Florida, United States, 33511
Meridien Research
Lakeland, Florida, United States, 33805
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, Illinois
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States, 60031
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Kansas
GTC Research
Shawnee, Kansas, United States, 66218
United States, Massachusetts
Beacon Clinical Research
Brockton, Massachusetts, United States, 02301
Beacon Clinical Research
New Bedford, Massachusetts, United States, 02740
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, New York
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States, 14221
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Lillestol Research, LLC
Fargo, North Dakota, United States, 58103
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Clinical Research Source, Inc.
Perrysberg, Ohio, United States, 43551
United States, Oklahoma
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Sunstone Medical Research, LLC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island
Omega Medical Research
Warick, Rhode Island, United States, 02886
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
Carolina Center for Rheumatology & Arthritis Care
Rock Hill, South Carolina, United States, 29732
United States, South Dakota
Meridian Clinical Research
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
United States, Washington
Swedish Rheumatology Research
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier: NCT01693692     History of Changes
Other Study ID Numbers: 0092
Study First Received: September 20, 2012
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Fibromyalgia

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

ClinicalTrials.gov processed this record on October 19, 2014