NCT00171431

Brief Summary

Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.5 years

First QC Date

September 12, 2005

Last Update Submit

April 19, 2012

Conditions

Constipation PredominantIrritable Bowel Syndrome (IBS-C)

Keywords

IBS-Cfemale

Outcome Measures

Primary Outcomes (2)

  • To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C

  • by using Multiple Intraluminal Impedance

Interventions

TegaserodDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female 18 and older
  • IBS-C patients diagnosed on the basis of Rome II criteria
  • Ability to comply with the requirements of the entire study

You may not qualify if:

  • Evidence of structural abnormality of the gastrointestinal tract or disease/conditions.
  • Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy.
  • Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

tegaserod

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

US(1)