Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
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|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)|
|Estimated 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|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141089
|Study Chair:||Novartis||Novartis Basel|