Trial Outcomes & Findings for Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions (NCT NCT01834729)

NCT ID: NCT01834729

Last Updated: 2019-01-29

Results Overview

A bowel movement is considered a spontaneous bowel movement (SBM) if no laxative, enema, or suppository was taken in the preceding 24 hours.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2019-01-29

Participant Flow

A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.

Participant milestones

Measure	Control Placebo Healthy subjects defined as not having a functional bowel disorder randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug.	Control Alfuzosin Healthy subjects defined as not having a functional bowel disorder randomized to this arm will receive a receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.	Constipation Placebo Subjects with constipation for 1 year or longer randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Constipation Alfuzosin Subjects with constipation for 1 year or longer randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
Overall Study STARTED	18	20	18	18
Overall Study COMPLETED	17	19	15	16
Overall Study NOT COMPLETED	1	1	3	2

Reasons for withdrawal

Measure	Control Placebo Healthy subjects defined as not having a functional bowel disorder randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug.	Control Alfuzosin Healthy subjects defined as not having a functional bowel disorder randomized to this arm will receive a receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.	Constipation Placebo Subjects with constipation for 1 year or longer randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Constipation Alfuzosin Subjects with constipation for 1 year or longer randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.
Overall Study Did not return bowel diaries	0	0	3	0
Overall Study Withdrawal by Subject	1	1	0	0
Overall Study Adverse Event	0	0	0	2

Baseline Characteristics

A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.

Baseline characteristics by cohort

Measure	Control Placebo n=18 Participants Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Control Alfuzosin n=20 Participants Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.	Constipation Placebo n=18 Participants Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Constipation Alfuzosin n=18 Participants In this arm, only constipated patients will receive oral alfuzosin (10 mg extended release (ER)) capsules. Alfuzosin: oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)	Total n=74 Participants Total of all reporting groups
Age, Continuous	32 years n=18 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	45 years n=20 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	36 years n=18 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	40 years n=18 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	40 years n=74 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.
Sex: Female, Male Female	18 Participants n=18 Participants	20 Participants n=20 Participants	18 Participants n=18 Participants	18 Participants n=18 Participants	74 Participants n=74 Participants
Sex: Female, Male Male	0 Participants n=18 Participants	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=74 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	20 participants n=20 Participants	18 participants n=18 Participants	18 participants n=18 Participants	74 participants n=74 Participants
Body mass index	24 kg/m^2 n=18 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	27 kg/m^2 n=20 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	25 kg/m^2 n=18 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	25 kg/m^2 n=18 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.	26 kg/m^2 n=74 Participants • A total of 38 healthy subjects and 36 subjects with constipation for 1 year or longer participated in the study. Both the healthy subjects and constipation subjects participated in Part A. Only the constipation subjects participated in Part B.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Placebo n=18 Participants Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Control Alfuzosin n=20 Participants Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.	Constipation Placebo n=18 Participants Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Constipation Alfuzosin n=18 Participants Constipated patients will receive oral alfuzosin (10 mg extended release (ER) capsules.
Weekly Rate of Spontaneous Bowel Movements at 4 Weeks	1.6 spontaneous bowel movements per week Standard Error 0.3	1.3 spontaneous bowel movements per week Standard Error 0.1	1.6 spontaneous bowel movements per week Standard Error 0.4	1.3 spontaneous bowel movements per week Standard Error 0.1

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Control Placebo n=18 Participants Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Control Alfuzosin n=20 Participants Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.	Constipation Placebo n=18 Participants Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Constipation Alfuzosin n=18 Participants Constipated patients will receive oral alfuzosin (10 mg extended release (ER) capsules.
Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks	0.6 complete SBM per week Standard Error 0.1	0.7 complete SBM per week Standard Error 0.05	0.7 complete SBM per week Standard Error 0.1	0.7 complete SBM per week Standard Error 0.1

Adverse Events

Control Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Alfuzosin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Constipation Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Constipation Afluzosin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Placebo n=18 participants at risk Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Control Alfuzosin n=20 participants at risk Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg.	Constipation Placebo n=18 participants at risk Subjects randomized to this arm will receive a placebo capsule identical to the study drug. Placebo: placebo capsule identical to the study drug	Constipation Afluzosin n=18 participants at risk Constipated patients will receive oral alfuzosin (10 mg extended release (ER)) capsules.
Cardiac disorders Hypotension	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	5.0% 1/20 • Number of events 1 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.
General disorders Headache	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/20 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	5.6% 1/18 • Number of events 1 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.
General disorders Fatigue	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/20 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	5.6% 1/18 • Number of events 1 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.
Gastrointestinal disorders Abdominal cramps	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/20 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	5.6% 1/18 • Number of events 1 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.	0.00% 0/18 • Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.

Additional Information

Dr. Adil E. Bharucha

Mayo Clinic

Phone: 507-284-2687

Email: bharucha.adil@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place