Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

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

Secondary 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.

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair East Hanover NJ  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142987

Study ID Number: CHTF919A2417

ClinicalTrials.gov Identifier: NCT00142987

Health Authority: United States: Food and Drug Administration