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Trial record 45 of 332 for:    clonidine

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

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: NCT00884832
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Adil Bharucha, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE April 17, 2009
First Posted Date  ICMJE April 21, 2009
Results First Submitted Date  ICMJE October 16, 2013
Results First Posted Date  ICMJE March 6, 2014
Last Update Posted Date March 6, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2014)
Mean Fecal Incontinence and Constipation Assessment (FICA) Score [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
The primary objective end-points are rectal capacity, rectal sensory thresholds for the desire to defecate (expressed as pressure and volume), urgency, and severity of FI (FICA score).
Change History Complete list of historical versions of study NCT00884832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2014)
  • Mean Number of Days With Fecal Incontinence [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
    Values were averaged over 4 week baseline and 4 week treatment periods.
  • Mean Number of Fecal Incontinence Episodes [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
    Values were averaged over 4 week baseline and 4 week treatment periods.
  • Mean Percentage of Bowel Movements Which Were Incontinent [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
    Values were averaged over 4 week baseline and 4 week treatment periods.
  • Mean Severity of Fecal Incontinence [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
    The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires.
  • Impact of Fecal Incontinence on Baseline Quality of Life [ Time Frame: 4 weeks baseline ]
    Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items). Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values).
  • Impact of Fecal Incontinence on Post-Treatment Quality of Life [ Time Frame: after 4 weeks treatment ]
    Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items). Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values).
  • Satisfaction With Treatment [ Time Frame: 4 weeks baseline, 4 week treatment ]
    This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = "Not satisfied at all (no relief of symptoms)" to 100 = "Completely satisfied (symptoms resolved)." The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.
  • Percentage of Bowel Movements Preceded by Rectal Urgency [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
    Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.
  • Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
    The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale.
  • Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline [ Time Frame: 4 weeks treatment ]
    The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. The "adjustment for baseline" was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.
  • Percentage of Days With Fecal Incontinence (FI) [ Time Frame: 4 weeks baseline, 4 weeks treatment ]
  • Percentage of Days With FI Post-treatment Adjusted for Baseline [ Time Frame: 4 weeks treatment ]
    The "adjustment for baseline" was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
The secondary objective endpoints are number of episodes of FI per week, proportion of incontinent days per week, adequate relief of FI, rectal urgency (proportion of bowel movements preceded by urgency), impact of FI on quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Official Title  ICMJE A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
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.
Detailed Description Available therapeutic options for idiopathic fecal incontinence (FI) are limited and unsatisfactory. In addition to weak anal sphincters, our data suggest that reduced rectal capacity may contribute to rectal hypersensitivity and the symptom of rectal urgency in FI. During a 4 week study, oral clonidine restored rectal capacity and improved fecal continence in women with urge-predominant FI. Clonidine improves fecal continence and stool consistency in diarrhea-predominant irritable bowel syndrome (IBS). Therefore, we now propose a placebo-controlled study of clonidine for FI. Our aims are to (i) compare the effects of clonidine and placebo, to be given for 4 weeks, on symptoms, anal pressures, rectal compliance and sensation in women with FI. Forty four women (18-75 y) with urge predominant "idiopathic" FI and ≥ 4 episodes of FI during a 4 week screening period will be recruited to this study. Thereafter, patients will be treated with clonidine or placebo for 4 weeks. Bowel symptoms will be recorded in a diary. Anal sphincter pressures, rectal compliance and sensation will be evaluated before and during treatment with clonidine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fecal Incontinence
Intervention  ICMJE
  • Drug: Clonidine
    Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
    Other Names:
    • Kapvay
    • Nexiclon
    • Catapres
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Experimental: Oral Clonidine
    Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
    Intervention: Drug: Clonidine
  • Placebo Comparator: Oral Placebo
    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.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2009)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00884832
Other Study ID Numbers  ICMJE 08-005892
R01DK078924 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adil Bharucha, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Adil E Bharucha, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP