A Multicentre Trial to Determine the Efficacy and Safety... | NCT00377039

Studies
A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia

NCT00377039

Sponsor

Sosei

Status

Completed

Last Update Posted

Oct 2, 2007Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Fibromyalgia

Interventions

AD 337

Countries

United Kingdom

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

Sep 2007

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

Aug 2006

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Sep 14, 2006

First Submission Date that Met QC Criteria

Sep 14, 2006

First Posted Date

Sep 15, 2006Estimated

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

Sep 30, 2007

Last Update Posted Date

Oct 2, 2007Estimated

Description Module

Brief Summary

This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
AD 337	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment

Secondary Outcomes

Measure	Description	Time Frame
These will be
FIQ Total score at weeks 1, 2, 3, at end of study and overall
FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Age 18-65
Meet ACR 1990 criteria for classification of Fibromyalgia
Able and willing to discontinue CNS active therapies

Exclusion Criteria:

If pain is NOT primarily due to Fibromyalgia
Current or prior history of serious psychiatric disorder
Pregnant/breastfeeding
QTc > 470ms
Failure to respond to 2 or more adequate regimes of different classes of antidepressants.

Accepts Healthy Volunteers

Sex

Female

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David L Scott	King's College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David L Scott		London			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided