Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00884832
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00884832
Study Brief:
Protocol Section:
NCT00884832