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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.
Information provided by:
Novartis Identifier:
First received: August 31, 2005
Last updated: January 24, 2008
Last verified: January 2008
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
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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female

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.

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Please refer to this study by its identifier: NCT00142987

Sponsors and Collaborators
Study Chair: Novartis East Hanover NJ
  More Information Identifier: NCT00142987     History of Changes
Other Study ID Numbers: CHTF919A2417
Study First Received: August 31, 2005
Last Updated: January 24, 2008

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

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 26, 2017