Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 12:51 PM
Study NCT ID:
NCT00884832
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2009-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bharucha.adil@mayo.edu', 'phone': '507-266-9156', 'title': 'Dr. Adil E. Bharucha', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.', 'otherNumAtRisk': 22, 'otherNumAffected': 19, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oral Placebo', 'description': '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.', 'otherNumAtRisk': 22, 'otherNumAffected': 7, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Fecal Incontinence and Constipation Assessment (FICA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline', 'categories': [{'measurements': [{'value': '8.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment', 'categories': [{'measurements': [{'value': '6.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Mean Number of Days With Fecal Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline', 'categories': [{'measurements': [{'value': '13', 'spread': '1', 'groupId': 'OG000'}, {'value': '16', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment', 'categories': [{'measurements': [{'value': '8', 'spread': '1', 'groupId': 'OG000'}, {'value': '11', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': 'Values were averaged over 4 week baseline and 4 week treatment periods.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Mean Number of Fecal Incontinence Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline', 'categories': [{'measurements': [{'value': '20', 'spread': '3', 'groupId': 'OG000'}, {'value': '31', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment', 'categories': [{'measurements': [{'value': '12', 'spread': '3', 'groupId': 'OG000'}, {'value': '19', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': 'Values were averaged over 4 week baseline and 4 week treatment periods.', 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Bowel Movements Which Were Incontinent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline', 'categories': [{'measurements': [{'value': '31', 'spread': '4', 'groupId': 'OG000'}, {'value': '40', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment', 'categories': [{'measurements': [{'value': '24', 'spread': '5', 'groupId': 'OG000'}, {'value': '27', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': 'Values were averaged over 4 week baseline and 4 week treatment periods.', 'unitOfMeasure': 'percentage of bowel movements', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Mean Severity of Fecal Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline', 'categories': [{'measurements': [{'value': '36.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment', 'categories': [{'measurements': [{'value': '29.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '31.2', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Impact of Fecal Incontinence on Baseline Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': 'Lifestyle score', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Coping score', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Depression score', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Embarrassment score', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline', 'description': '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).\n\nScales 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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Impact of Fecal Incontinence on Post-Treatment Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': 'Lifestyle score', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Coping score', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Depression score', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Embarrassment score', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks treatment', 'description': '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).\n\nScales 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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline', 'categories': [{'measurements': [{'value': '22', 'spread': '6', 'groupId': 'OG000'}, {'value': '18', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment', 'categories': [{'measurements': [{'value': '47', 'spread': '6', 'groupId': 'OG000'}, {'value': '38', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 week treatment', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Bowel Movements Preceded by Rectal Urgency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline', 'categories': [{'measurements': [{'value': '55', 'spread': '4', 'groupId': 'OG000'}, {'value': '59', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment', 'categories': [{'measurements': [{'value': '46', 'spread': '6', 'groupId': 'OG000'}, {'value': '46', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.', 'unitOfMeasure': 'percentage of bowel movements', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline, subjects without diarrhea', 'categories': [{'measurements': [{'value': '19.4', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': '4 weeks baseline, subjects with diarrhea', 'categories': [{'measurements': [{'value': '47.5', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '51.6', 'spread': '6.4', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment, subjects without diarrhea', 'categories': [{'measurements': [{'value': '14', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '16', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment, subjects with diarrhea', 'categories': [{'measurements': [{'value': '31.2', 'spread': '7', 'groupId': 'OG000'}, {'value': '49', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.', 'unitOfMeasure': 'percentage of bowel movements', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': 'Subjects with diarrhea', 'categories': [{'measurements': [{'value': '23.6', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Subjects without diarrhea', 'categories': [{'measurements': [{'value': '25.4', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'drug\\*group interactions', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks treatment', 'description': '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.', 'unitOfMeasure': 'percentage of bowel movements', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With Fecal Incontinence (FI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': '4 weeks baseline, subjects without diarrhea', 'categories': [{'measurements': [{'value': '28.7', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': '4 weeks baseline, subjects with diarrhea', 'categories': [{'measurements': [{'value': '35.4', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment, subjects without diarrhea', 'categories': [{'measurements': [{'value': '23.2', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': '4 weeks treatment, subjects with diarrhea', 'categories': [{'measurements': [{'value': '24.3', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With FI Post-treatment Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': '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.'}], 'classes': [{'title': 'Subjects without diarrhea', 'categories': [{'measurements': [{'value': '42.54', 'spread': '5.92', 'groupId': 'OG000'}, {'value': '31.42', 'spread': '6.97', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with diarrhea', 'categories': [{'measurements': [{'value': '27.79', 'spread': '6.97', 'groupId': 'OG000'}, {'value': '39.51', 'spread': '5.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.082', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks treatment', 'description': 'The "adjustment for baseline" was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'FG001', 'title': 'Oral Placebo', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted between January 2009 and April 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.'}, {'id': 'BG001', 'title': 'Oral Placebo', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '10.88', 'groupId': 'BG000'}, {'value': '57', 'spread': '11.86', 'groupId': 'BG001'}, {'value': '57.38', 'spread': '11.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '1.09', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '6.35', 'groupId': 'BG001'}, {'value': '29.14', 'spread': '5.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hysterectomy', 'classes': [{'title': 'Hysterectomy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'No Hysterectomy', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who had previously had a hysterectomy at baseline.', 'unitOfMeasure': 'participants'}, {'title': 'Functional diarrhea or Diarrhea-predominant Irritable Bowel Syndrome (IBS)', 'classes': [{'title': 'Subjects with diarrhea', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Subjects without diarrhea', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2009-04-17', 'resultsFirstSubmitDate': '2013-10-16', 'studyFirstSubmitQcDate': '2009-04-20', 'lastUpdatePostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-20', 'studyFirstPostDateStruct': {'date': '2009-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Fecal Incontinence and Constipation Assessment (FICA) Score', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Number of Days With Fecal Incontinence', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': 'Values were averaged over 4 week baseline and 4 week treatment periods.'}, {'measure': 'Mean Number of Fecal Incontinence Episodes', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': 'Values were averaged over 4 week baseline and 4 week treatment periods.'}, {'measure': 'Mean Percentage of Bowel Movements Which Were Incontinent', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': 'Values were averaged over 4 week baseline and 4 week treatment periods.'}, {'measure': 'Mean Severity of Fecal Incontinence', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.'}, {'measure': 'Impact of Fecal Incontinence on Baseline Quality of Life', 'timeFrame': '4 weeks baseline', 'description': '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).\n\nScales 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).'}, {'measure': 'Impact of Fecal Incontinence on Post-Treatment Quality of Life', 'timeFrame': 'after 4 weeks treatment', 'description': '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).\n\nScales 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).'}, {'measure': 'Satisfaction With Treatment', 'timeFrame': '4 weeks baseline, 4 week treatment', 'description': '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.'}, {'measure': 'Percentage of Bowel Movements Preceded by Rectal Urgency', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.'}, {'measure': 'Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea', 'timeFrame': '4 weeks baseline, 4 weeks treatment', 'description': '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.'}, {'measure': 'Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline', 'timeFrame': '4 weeks treatment', 'description': '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.'}, {'measure': 'Percentage of Days With Fecal Incontinence (FI)', 'timeFrame': '4 weeks baseline, 4 weeks treatment'}, {'measure': 'Percentage of Days With FI Post-treatment Adjusted for Baseline', 'timeFrame': '4 weeks treatment', 'description': 'The "adjustment for baseline" was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fecal incontinence', 'stool leakage', 'incontinence', 'FI', 'Urge predominant fecal incontinence'], 'conditions': ['Fecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '23891925', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Absence of organic disease (i.e., ulcerative colitis, cancer) as evidenced by colonoscopy, or barium enema and sigmoidoscopy within the last 3 years\n\nExclusion Criteria:\n\n* 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)\n* 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\n* Neurological disorders - Spinal cord injuries, dementia (Mini-mental status score \\<20/25), multiple sclerosis, Parkinson's disease, peripheral neuropathy\n* Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of \\<100 mm Hg on initial screening visit\n* Pregnant or nursing women\n* Severe diarrhea during the run in phase defined as greater than 6 liquid stools daily (Bristol 6 or 7)\n* 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\\]\n* Medications: Relative - other antihypertensive agents (i.e., if there is concern about synergistic effects and hypotension)"}, 'identificationModule': {'nctId': 'NCT00884832', 'briefTitle': 'A Placebo-Controlled Study of Clonidine for Fecal Incontinence.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Placebo-Controlled Study of Clonidine for Fecal Incontinence.', 'orgStudyIdInfo': {'id': '08-005892'}, 'secondaryIdInfos': [{'id': 'R01DK078924', 'link': 'https://reporter.nih.gov/quickSearch/R01DK078924', 'type': 'NIH'}, {'id': 'UL1RR024150', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024150', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Clonidine', 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.', 'interventionNames': ['Drug: Clonidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['Kapvay', 'Nexiclon', 'Catapres'], 'description': 'Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.', 'armGroupLabels': ['Oral Clonidine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Oral Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Adil E Bharucha, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Adil Bharucha', 'investigatorAffiliation': 'Mayo Clinic'}}}}