An Evaluation of the Efficacy and Safety of Tegaserod 6 m... | NCT00139568

Studies
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation

NCT00139568

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 1, 2008Estimated

Enrollment

600

Phase

Phase 3

Conditions

Constipation

Interventions

Tegaserod

Countries

Switzerland

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

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

Oct 2005Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Aug 31, 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

Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women

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

600

Name	Type	Description	Arm Group Labels	Other Names
Tegaserod	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in number of complete spontaneous bowel movements (CSBM) per week

Secondary Outcomes

Measure	Description	Time Frame
Response rate for CSBM during the first 4 weeks of treatment
Patients' daily assessment of bowel habits
Patients' weekly assessment of constipation symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men or women at least 18 years of age
History of constipation for at least 6 months prior to screening
Normal bowel evaluation performed within the past 5 years

Exclusion Criteria:

Most bothersome symptom in last 6 months is abdominal pain/discomfort
Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy
Insulin dependent diabetes
Evidence of cathartic colon or laxative abuse

Other inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

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	Novartis Basel, Switzerland	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		Basel		4056	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C105050	tegaserod

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided