Constipation
Conditions
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.
Interventions
DRUGAlfuzosin
oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)
OTHERPlacebo
placebo capsule identical to the study drug
Sponsors
National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
for controls (Part A only): * Healthy * Able to provide written informed consent before participating in the study * Able to communicate adequately with the investigator and to comply with the requirements for the entire study. Inclusion criteria for patients (Parts A and B): * Women with chronic constipation for 1 year with any 2 or more of the following symptoms for 3 months or longer, i.e. \<3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time. * Able to provide written informed consent before participating in the study * Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
Exclusion criteria
for controls (Part A); Items indicated with an asterisk (\*) are also
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Placebo Subjects randomized to this arm will receive a placebo capsule identical to the study drug.
Placebo: placebo capsule identical to the study drug | 18 |
| Control Alfuzosin Subjects randomized to this arm will receive a single dose of oral alfuzosin immediate release (IR) 2.5 mg. | 20 |
| Constipation Placebo Subjects randomized to this arm will receive a placebo capsule identical to the study drug.
Placebo: placebo capsule identical to the study drug | 18 |
| Constipation Alfuzosin 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) | 18 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 2 |
| Overall Study | Did not return bowel diaries | 0 | 0 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Control Placebo | Control Alfuzosin | Constipation Placebo | Constipation Alfuzosin | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32 years | 45 years | 36 years | 40 years | 40 years |
| Body mass index | 24 kg/m^2 | 27 kg/m^2 | 25 kg/m^2 | 25 kg/m^2 | 26 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 18 participants | 20 participants | 18 participants | 18 participants | 74 participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 18 Participants | 18 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 1 / 20 | 1 / 18 | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Weekly Rate of Complete Spontaneous Bowel Movements at 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).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Placebo | Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | 0.6 complete SBM per week | Standard Error 0.1 |
| Control Alfuzosin | Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | 0.7 complete SBM per week | Standard Error 0.05 |
| Constipation Placebo | Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | 0.7 complete SBM per week | Standard Error 0.1 |
| Constipation Alfuzosin | Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks | 0.7 complete SBM per week | Standard Error 0.1 |
p-value: 0.57Least squares means
Primary
Weekly Rate of Spontaneous Bowel Movements at 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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Placebo | Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | 1.6 spontaneous bowel movements per week | Standard Error 0.3 |
| Control Alfuzosin | Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | 1.3 spontaneous bowel movements per week | Standard Error 0.1 |
| Constipation Placebo | Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | 1.6 spontaneous bowel movements per week | Standard Error 0.4 |
| Constipation Alfuzosin | Weekly Rate of Spontaneous Bowel Movements at 4 Weeks | 1.3 spontaneous bowel movements per week | Standard Error 0.1 |
p-value: 0.78Least squares means