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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

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ClinicalTrials.gov Identifier: NCT00142987
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 28, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
IBS-C and IBS With Mixed Bowel Habits Drug: Tegaserod Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2004
Study Completion Date : June 2005

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Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142987


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

ClinicalTrials.gov Identifier: NCT00142987     History of Changes
Other Study ID Numbers: CHTF919A2417
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 28, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
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
Physiological Effects of Drugs