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

NCT00142987 | Completed Phase 4

• 1 other identifier: CHTF919A2417
• Study Type: interventional
• Target: 664
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IBS-C and IBS With Mixed Bowel Habits

Keywords

Tegaserod, IBS-C, women, mixed bowel habit

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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.

Interventions

Tegaserod DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Interventions

tegaserod

Study Officials

• Novartis

  East Hanover NJ

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: April 1, 2004
• Study Completion: June 1, 2005
• Last Updated: January 28, 2008

Record last verified: 2008-01