NCT00884832

Brief Summary

Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 6, 2014

Completed
Last Updated

March 6, 2014

Status Verified

January 1, 2014

Enrollment Period

3.8 years

First QC Date

April 17, 2009

Results QC Date

October 16, 2013

Last Update Submit

January 20, 2014

Conditions

Fecal Incontinence

Keywords

fecal incontinencestool leakageincontinenceFIUrge predominant fecal incontinence

Outcome Measures

Primary Outcomes (1)

  • Mean Fecal Incontinence and Constipation Assessment (FICA) Score

    The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1-6, 7-10, and 11-13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.

    4 weeks baseline, 4 weeks treatment

Secondary Outcomes (12)

  • Mean Number of Days With Fecal Incontinence

    4 weeks baseline, 4 weeks treatment

  • Mean Number of Fecal Incontinence Episodes

    4 weeks baseline, 4 weeks treatment

  • Mean Percentage of Bowel Movements Which Were Incontinent

    4 weeks baseline, 4 weeks treatment

  • Mean Severity of Fecal Incontinence

    4 weeks baseline, 4 weeks treatment

  • Impact of Fecal Incontinence on Baseline Quality of Life

    4 weeks baseline

  • +7 more secondary outcomes

Study Arms (2)

Oral Clonidine

EXPERIMENTAL

Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.

Drug: Clonidine

Oral Placebo

PLACEBO COMPARATOR

Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.

Drug: Placebo

Interventions

ClonidineDRUG

Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.

Also known as: Kapvay, Nexiclon, Catapres
Oral Clonidine
PlaceboDRUG

Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.

Oral Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18-75 years with urge predominant FI, as defined by a validated questionnaire, for greater than or equal to 1 year duration will be eligible to participate
  • Absence of organic disease (i.e., ulcerative colitis, cancer) as evidenced by colonoscopy, or barium enema and sigmoidoscopy within the last 3 years

You may not qualify if:

  • History of clinically significant cardiovascular or pulmonary disease or EKG abnormalities within the last 6 months \[i.e., atrial flutter or fibrillation, sinus tachycardia (\> 110/minute) or bradycardia (\< 45 beats/minute), or prolonged corrected QT (QTc) interval (\> 460 msec)
  • Current or past history of rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, greater than or equal to Grade 2 rectal prolapse, history of rectal resection or pelvic irradiation
  • Neurological disorders - Spinal cord injuries, dementia (Mini-mental status score \<20/25), multiple sclerosis, Parkinson's disease, peripheral neuropathy
  • Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of \<100 mm Hg on initial screening visit
  • Pregnant or nursing women
  • Severe diarrhea during the run in phase defined as greater than 6 liquid stools daily (Bristol 6 or 7)
  • Medications: Absolute - opioid analgesics, anticholinergic drugs \[low doses of tricyclic antidepressants, e.g., nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) will be permitted provided they were begun 3 months prior to the screening period\]
  • Medications: Relative - other antihypertensive agents (i.e., if there is concern about synergistic effects and hypotension)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Bharucha AE, Fletcher JG, Camilleri M, Edge J, Carlson P, Zinsmeister AR. Effects of clonidine in women with fecal incontinence. Clin Gastroenterol Hepatol. 2014 May;12(5):843-851.e2; quiz e44. doi: 10.1016/j.cgh.2013.06.035. Epub 2013 Jul 23.

    PMID: 23891925DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Adil E. Bharucha
Organization
Mayo Clinic
bharucha.adil@mayo.edu
507-266-9156

Study Officials

  • Adil E Bharucha, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 21, 2009

Study Start

October 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 6, 2014

Results First Posted

March 6, 2014

Record last verified: 2014-01

Locations

US(1)