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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01834729
Recruitment Status : Completed
First Posted : April 18, 2013
Results First Posted : January 11, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Adil Bharucha, 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.

Condition or disease Intervention/treatment Phase
Constipation Drug: Alfuzosin Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: 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.

Drug: Alfuzosin
oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)
Other Names:
  • Xatral (immediate release 2.5 mg)
  • Uroxatral (extended release 10 mg)

Placebo Comparator: Placebo
Subjects randomized to this arm will receive a single placebo capsule identical to the study drug.
Other: Placebo
placebo capsule identical to the study drug




Primary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 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):

    1. 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
    2. 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.*
    3. 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.

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Adil Bharucha, MBBS, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Adil Bharucha, Mayo Clinic:

Publications of Results:
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Responsible Party: Adil Bharucha, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01834729    
Other Study ID Numbers: 12-006090
1UL1RR024150 ( U.S. NIH Grant/Contract )
R01DK078924 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2013    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents