GW679769 In Fibromyalgia | NCT00264628

Studies
GW679769 In Fibromyalgia

NCT00264628

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Apr 16, 2015Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Depressive Disorder
Depression
Fibromyalgia

Interventions

GW679769

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Dec 9, 2005

First Submission Date that Met QC Criteria

Dec 12, 2005

First Posted Date

Dec 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2015

Last Update Posted Date

Apr 16, 2015Estimated

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Name	Type	Description	Arm Group Labels	Other Names
GW679769	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Fibromyalgia Impact Questionnaire (FIQ) total score		throughout study

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D003863	Depression
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531951	casopitant

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided