ConstipationPhase 2NCT01834729

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

A Phase 2 study testing Alfuzosin in people with Constipation, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for: Constipation
What is being tested?: Alfuzosin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteUnited States
Study dates: Mar 2013to 6 Sep 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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.

Show all 22Show fewer

Exclusion criteria for controls (Part A); Items indicated with an asterisk () are also exclusion criteria for patients (Parts A and B):
Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*
Current symptomatic orthostatic hypotension or history of hypotensive response as defined by a reduction of ≥ 30 mmHg in systolic or ≥ 20 mmHg in diastolic blood pressure.*
Current symptoms of a functional gastrointestinal disorder assessed by questionnaire.
Putative risk factors for pelvic floor trauma, i.e. six or more vaginal deliveries, birthweight >4500gms (macrosomia), or known 4th degree perineal tear.
Inability to withdraw medications prior to the baseline period and throughout the study (except as protocol defined rescue medications):
Medications that substantially alter GI transit* including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, narcotics, anti-cholinergics, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRI) and newer antidepressants
Selective serotonin reuptake inhibitor (SSRI) antidepressants are permissible at low, stable doses. All medications shall be reviewed and dis/approved by the principal investigator on a case by case basis.*
Potent Cytochrome P450 3A4 (Cyp3A4) inhibitors such as ketoconazole, itraconazole and ritonavir, nitrates and phosphodiesterase inhibitors.* Note: stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible.*
Stable dose of thyroxine will be permitted*
Prolonged Q-Tc interval > 500 msec on ECG within the last three months*
Estimated glomerular filtration rate (eGFR) < 60 mL/minute. * Based on guidelines and recommendations from the National Kidney Disease Education Program (NKDEP) of the National Institutes of Health (NIH) and the Kidney Disease Outcomes Quality Initiative (KDOQI) of the National Kidney Foundation, the an eGFR using the Modification of Diet in Renal Disease (MDRD) Study equation is more accurate than a creatinine clearance calculated from serum and urine measurements. The formula is eGFR (mL/min/1.73 m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African American). Based on our extensive experience in clinical practice and research studies, it is anticipated that all potentially eligible participants will have normal serum creatinine.
History of allergies to alpha-1 adrenoreceptor antagonist*
Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease*
Pregnant women, prisoners and institutionalized individuals*
Persons with a latex allergy.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Effect of Stress and a Alpha-1 Antagonist on Anorectal Functions

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.

Read the 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.

Conditions: Constipation
Being tested: Alfuzosin, Placebo
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlfuzosinDrug
Also called Xatral (immediate release 2.5 mg), Uroxatral (extended release 10 mg)
oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)
PlaceboOther
placebo capsule identical to the study drug

Study groups in NCT01834729
Study group	Role	What they receive
Alfuzosin	Experimental	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. Receives: Drug: Alfuzosin
Placebo	Placebo comparator	Subjects randomized to this arm will receive a single placebo capsule identical to the study drug. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks
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).
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 20136 Sep 2017

First posted18 Apr 2013 (estimated)
Study startMar 2013
Primary completion6 Sep 2017
Study completion6 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ConstipationStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01834729
Sponsor's protocol ID: 12-006090
Other IDs: 1UL1RR024150, R01DK078924
Status last verified: Jan 2019
First submitted: 15 Apr 2013
Last updated: 29 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Chakraborty S, Feuerhak K, Muthyala A, Harmsen WS, Bailey KR, Bharucha AE. Effects of Alfuzosin, an alpha1-Adrenergic Antagonist, on Anal Pressures and Bowel Habits in Women With and Without Defecatory Disorders. Clin Gastroenterol Hepatol. 2019 May;17(6):1138-1147.e3. doi: 10.1016/j.cgh.2018.08.036. Epub 2018 Aug 18.
PubMed 30130627

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Stress and a Alpha-1 Antagonist on Anorectal Functions
ClinicalTrials.gov ID: NCT01834729
Acronym / sponsor ID: 12-006090
Conditions: Constipation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Mar 2013 (actual)
Primary completion: 6 Sep 2017 (actual)
Study completion: 6 Sep 2017 (actual)
First posted: 18 Apr 2013 (estimated)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Alfuzosin	Experimental	Drug: AlfuzosinIn 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.
Placebo	Placebo comparator	Other: PlaceboSubjects randomized to this arm will receive a single placebo capsule identical to the study drug.

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

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.
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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlfuzosinAlso: Xatral (immediate release 2.5 mg), Uroxatral (extended release 10 mg)oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)	Drug	Alfuzosin
Placeboplacebo capsule identical to the study drug	Other	Placebo

Primary outcome

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).

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Placebo	18	17
Control Alfuzosin	20	19
Constipation Placebo	18	15
Constipation Alfuzosin	18	16

Primary outcome: Weekly Rate of Spontaneous Bowel Movements at 4 Weeks

Time frame: 4 weeks. Mean (Standard Error). Unit: spontaneous bowel movements per week

Measure	Control Placebo n = 18	Control Alfuzosin n = 20	Constipation Placebo n = 18	Constipation Alfuzosin n = 18
Value	1.6 (0.3)	1.3 (0.1)	1.6 (0.4)	1.3 (0.1)

Constipation Placebo vs Constipation Alfuzosin: p = 0.78, Least squares means

Primary outcome: Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks

Time frame: 4 weeks. Mean (Standard Error). Unit: complete SBM per week

Measure	Control Placebo n = 18	Control Alfuzosin n = 20	Constipation Placebo n = 18	Constipation Alfuzosin n = 18
Value	0.6 (0.1)	0.7 (0.05)	0.7 (0.1)	0.7 (0.1)

Constipation Placebo vs Constipation Alfuzosin: p = 0.57, Least squares means

Adverse events

Time frame: Subject safety monitoring was performed for six hours after treatment in healthy patients and two weeks in constipated patients.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Placebo	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Control Alfuzosin	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Constipation Placebo	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18
Constipation Afluzosin	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18

Limitations and caveats (from the sponsor): Men were not studied; baseline bowel diary was not preceded by a run-in period; treatment phase only lasted 2 weeks.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30130627Chakraborty S, Feuerhak K, Muthyala A, Harmsen WS, Bailey KR, Bharucha AE. Effects of Alfuzosin, an alpha1-Adrenergic Antagonist, on Anal Pressures and Bowel Habits in Women With and Without Defecatory Disorders. Clin Gastroenterol Hepatol. 2019 May;17(6):1138-1147.e3. doi: 10.1016/j.cgh.2018.08.036. Epub 2018 Aug 18.

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adil Bharucha, MBBS, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alfuzosin in people with Constipation, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weekly Rate of Spontaneous Bowel Movements at 4 Weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01834729, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.