GW679769 In Fibromyalgia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00264628

First received: December 9, 2005

Last updated: April 15, 2015

Last verified: April 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

December 9, 2005

Last Updated Date

April 15, 2015

Start Date ^ICMJE

October 2005

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change in Fibromyalgia Impact Questionnaire (FIQ) total score from start to end of treatment.

Change History

Complete list of historical versions of study NCT00264628 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Effect of GW679769 vs placebo in health-related quality of life outcomes.
Relationship between PK of GW679769 and clinical outcome in patients.
Safety and Tolerability

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

GW679769 In Fibromyalgia

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Depressive Disorder
Depression
Fibromyalgia

Intervention ^ICMJE

Drug: GW679769

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Italy

Administrative Information

NCT Number ^ICMJE

NCT00264628

Other Study ID Numbers ^ICMJE

SND103929

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

April 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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