Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions

Phase 2

Completed

• Conditions: Constipation
• Interventions: Other: Placebo; Drug: Alfuzosin

• Registration Number: NCT01834729
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is designed to better understand the effects of effects of stress, relaxation, and a medication alfuzosin on bowel control and emptying in healthy people and patients with bowel problems.

Detailed Description

Normally, bowel emptying requires relaxation of the anal sphincter (i.e., lowermost end of intestinal tract) and pelvic muscles. Some people cannot relax these muscles normally and experience constipation. Alfuzosin is a medication which is approved to treat bladder but not bowel problems.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Primary Completion: 2017-09-06
• Study Completion: 2017-09-06
• Results First Submitted: 2018-11-15
• Results First Submitted QC: 2018-12-18
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Results First Posted: 2019-01-11
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects randomized to this arm will receive a single placebo capsule identical to the study drug.
Alfuzosin	Alfuzosin	In Part A, subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg. In Part B, only constipated patients will receive oral alfuzosin (10 mg extended release (ER)) capsules.

Primary Outcome Measures

Name	Time	Method
Weekly Rate of Spontaneous Bowel Movements at 4 Weeks	4 weeks	A bowel movement is considered a spontaneous bowel movement (SBM) if no laxative, enema, or suppository was taken in the preceding 24 hours.
Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks	4 weeks	If the subject indicates that the spontaneous bowel movement (SBM) was associated with a sensation of complete bowel emptying, the SBM will be counted as a complete spontaneous bowel movement (CSBM).

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States