GW679769 In Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00264628
First received: December 9, 2005
Last updated: October 13, 2008
Last verified: October 2008
  Purpose

The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769 up to 120 mg dose compared to placebo in patients with ACR(American College of Rheumatology)-defined fibromyalgia, co-morbid with depression.


Condition Intervention Phase
Fibromyalgia
Depression
Drug: GW679769
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Outpatient, Randomised, Double-Blind, Placebo Controlled, Parallel Group Exploratory Study to Evaluate Safety, Tolerability and Efficacy of GW679769 in Patients With Fibromyalgia Syndrome Comorbid With Depression.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in Fibromyalgia Impact Questionnaire (FIQ) total score [ Time Frame: throughout study ]

Secondary Outcome Measures:
  • Effect of GW679769 vs placebo in health-related quality of life outcomes [ Time Frame: throughout study ]
  • Relationship between PK of GW679769 and clinical outcome in patients [ Time Frame: throughout study ]
  • Safety and Tolerability [ Time Frame: throughout study ]

Enrollment: 8
Study Start Date: October 2005
Study Completion Date: September 2006
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of fibromyalgia (ACR criteria).
  • Non-severe depression (HAM-D score >14 <24).
  • Women must commit to consistent use of an acceptable method of birth control.

Exclusion criteria:

  • Severe depression (HAM-D score > 24).
  • Unable to discontinue medications for pain or depression.
  • Laboratory and ECG value at screening outside sponsor defined ranges.
  • Positive to stool occult blood test.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264628

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00264628     History of Changes
Other Study ID Numbers: SND103929
Study First Received: December 9, 2005
Last Updated: October 13, 2008
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by GlaxoSmithKline:
Fibromyalgia
Depression
NK1-antagonist
GW679769
Outpatient

Additional relevant MeSH terms:
Depression
Depressive Disorder
Fibromyalgia
Myofascial Pain Syndromes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014