Efficacy, Safety and Tolerability of Tegaserod in Patient... | NCT00149877

Studies
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

NCT00149877

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 1, 2008Estimated

Enrollment

250

Phase

Phase 4

Conditions

Chronic 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

Apr 2004

Primary Completion Date

Not provided

Completion Date

Feb 2006Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 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 (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250

Name	Type	Description	Arm Group Labels	Other Names
Tegaserod	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.

Secondary Outcomes

Measure	Description	Time Frame
Number of csbm during 8 weeks of treatment.
Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and females of at least 18 years of age
A 12-month history of constipation (defined as < three spontaneous bowel movements per week and ≥1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining)

Exclusion Criteria:

Patients with cancer, inflammatory bowel disease or other structural bowel disease
Patients who participated in a prior tegaserod study
Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

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	Basel	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		Basel		4056	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
C105050	tegaserod

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided