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OpenTrials
Completed

NCT Number: NCT00142987

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tegaserod

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Sep 2, 2005
Registry last updated
Jan 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.