Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00142987
First received: August 31, 2005
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits, excluding those with predominant diarrhea.


Condition Intervention Phase
IBS-C and IBS With Mixed Bowel Habits
Drug: Tegaserod
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms

Secondary Outcome Measures:
  • Weekly assessment of patient's overall satisfaction relief.
  • Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency.
  • During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS.
  • Assessment of safety and tolerability.

Estimated Enrollment: 664
Study Start Date: April 2004
Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits
  • In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool.
  • Had to fulfill the following criteria (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts

Exclusion Criteria:

  • IBS-D
  • not reporting any constipation and diarrhea criteria
  • evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
  • history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
  • evidence of cathartic colon or history of laxative abuse

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142987

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis East Hanover NJ
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00142987     History of Changes
Other Study ID Numbers: CHTF919A2417
Study First Received: August 31, 2005
Last Updated: January 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Tegaserod, IBS-C, women, mixed bowel habit

Additional relevant MeSH terms:
Habits
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014