GW679769 In Fibromyalgia

NCT ID: NCT00264628

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder Depression Fibromyalgia

Interventions

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GW679769

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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SND103929

Identifier Type: -

Identifier Source: org_study_id

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