NCT00264628

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2005

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

December 9, 2005

Last Update Submit

April 15, 2015

Conditions

Depressive DisorderDepressionFibromyalgia

Keywords

NK1-antagonistDepressionFibromyalgiaGW679769Outpatient

Outcome Measures

Primary Outcomes (1)

  • Change in Fibromyalgia Impact Questionnaire (FIQ) total score

    throughout study

Secondary Outcomes (3)

  • Effect of GW679769 vs placebo in health-related quality of life outcomes

    throughout study

  • Relationship between PK of GW679769 and clinical outcome in patients

    throughout study

  • Safety and Tolerability

    throughout study

Interventions

GW679769DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive DisorderDepressionFibromyalgia

Interventions

casopitant

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehaviorMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 13, 2005

Study Start

October 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

April 16, 2015

Record last verified: 2015-04