Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149877
• Other study ID #: CHTF919EHK01
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: January 31, 2008
• Start date: April 2004
• Est. completion date: February 2006

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and females of at least 18 years of age

• A 12-month history of constipation (defined as < three spontaneous bowel movements per week and =1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining)

Exclusion Criteria:

• Patients with cancer, inflammatory bowel disease or other structural bowel disease

• Patients who participated in a prior tegaserod study

• Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
Secondary	Number of csbm during 8 weeks of treatment.
Secondary	Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
Secondary	Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
Secondary	Laxative use.
Secondary	Safety and tolerability.