Extension Study to Assess the Long-Term Safety of Tegaser... | NCT00232102

Studies
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

NCT00232102

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 1, 2008Estimated

Enrollment

423

Phase

Phase 3

Conditions

Dyspepsia

Interventions

Tegaserod

Countries

United States

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

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Aug 2006Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Oct 3, 2005

First Posted Date

Oct 4, 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

Jan 31, 2008

Last Update Posted Date

Feb 1, 2008Estimated

Description Module

Brief Summary

This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

423

Name	Type	Description	Arm Group Labels	Other Names
Tegaserod	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term safety at 6 months.

Secondary Outcomes

Measure	Description	Time Frame
Long term safety at 1 year.
Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionnaire.
Efficacy on satisfactory relief at month 6 and 12.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, 18 years and older
Fulfilled eligibility criteria in CHTF919 D2302 (double blind study) and successfully completed the double-blind study

Exclusion Criteria:

- Early discontinuation from the double-blind study

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	East Hanover NJ	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		East Hanover	New Jersey	07936-108	United States

References Module

Citations

Not provided

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms