Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
|ClinicalTrials.gov Identifier: NCT00141089|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : February 1, 2008
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.
The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: Tegaserod||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1026 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||February 2005|
- Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
- For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm.
- Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use.
- Safety and tolerability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141089
|Study Chair:||Novartis||Novartis Basel|