IBS-C and IBS With Mixed Bowel Habits Clinical Trial
Official title:
Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
| Verified date | January 2008 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 664 |
| Est. completion date | June 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms | |||
| Secondary | Weekly assessment of patient's overall satisfaction relief. | |||
| Secondary | Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency. | |||
| Secondary | During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS. | |||
| Secondary | Assessment of safety and tolerability. |