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

History of Changes

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:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

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 (Adult)
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

Show 34 Study Locations

Sponsors and Collaborators

Theravance Biopharma R & D, Inc.

More Information


Responsible Party:	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 September 27, 2016

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