Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions
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|ClinicalTrials.gov Identifier: NCT01834729|
Recruitment Status : Completed
First Posted : April 18, 2013
Results First Posted : January 11, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: Alfuzosin Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Stress and a Alpha-1 Antagonist on Anorectal Functions|
|Actual Study Start Date :||March 2013|
|Actual Primary Completion Date :||September 6, 2017|
|Actual Study Completion Date :||September 6, 2017|
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.
oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)
Placebo Comparator: Placebo
Subjects randomized to this arm will receive a single placebo capsule identical to the study drug.
placebo capsule identical to the study drug
- Weekly Rate of Spontaneous Bowel Movements at 4 Weeks [ Time Frame: 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 [ Time Frame: 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).
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): NCT01834729
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Adil Bharucha, MBBS, MD||Mayo Clinic|