Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT00153127
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'statusVerifiedDate': '2013-02', 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria'}], 'secondaryOutcomes': [{'measure': 'Analysis of individual ROME I criteria'}, {'measure': 'Safety (adverse event and laboratory testing)'}]}, 'conditionsModule': {'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female ambulatory outpatient age 19 or older.\n* Patients meet ROME II Criteria\n* Patients not meeting ROME IBS criteria\n* Use of a constipating medication (\\>= 3% in PDR)\n* If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study\n* Written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.\n* Prior small bowel or colonic resection or colostomy.\n* Weight \\< 80 lbs.\n* Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.\n* Positive stool hemoccult.\n* Significant cardiac, renal or hepatic insufficiency.\n* Pregnant or expecting to become pregnant within 120 days of study enrollment.\n* Lactating or breast feeding.\n* Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.\n* Use of investigational drugs in the last 30 days.\n* Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions'}, 'identificationModule': {'nctId': 'NCT00153127', 'briefTitle': 'Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braintree Laboratories'}, 'officialTitle': 'Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications', 'orgStudyIdInfo': {'id': '851-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'polyethyleneglycol3350', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'overallOfficials': [{'name': 'Jorge Herrera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Alabama'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braintree Laboratories', 'class': 'INDUSTRY'}}}}