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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

CLINICAL, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP OF 4 WEEKS OF DURATION TO EVALUATE THE EFFICACY OF TEGASEROD IN THE RELIEF OF THE SYMPTOMS OF PATIENTS OF FEMALE SEX WITH IRRITABLE BOWEL SYNDROME (SII), EXCLUDING THOSE WHO SUFFER IBS WITH DIARRHEA WITH PREDOMINANT SYMPTOM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-014-04
Enrollment
63
Registered
2004-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Tegaserod 6 mg b.i.d. Type of group
Tegaserod 6 mg b.i.d. for 29 days Group name:placebo Type of group
placebo is administered from Tegaserod 6 mg b.i.d. for 29 days

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Outcome name:Criteria of constipation and diarrhea Rome II Measure:Weekly evaluation of relief of general patient satisfaction during 4 weeks of treatment of symptoms of irritable bowel syndrome. Timepoints:4 weeks—

Secondary

MeasureTime frame
Outcome name:Monitoring and recording of all adverse events and all serious adverse events, in the periodic monitoring of vital signs and in the performance of physical examinations. Measure:Evaluation of safety and tolerability. Timepoints:4 weeks—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)