Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-29 @ 3:24 AM
Study NCT ID:
NCT01027260
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2009-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2009-12-04', 'studyFirstSubmitQcDate': '2009-12-04', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"', 'timeFrame': '2 weeks and 4 weeks after the start of the treatment'}], 'secondaryOutcomes': [{'measure': 'Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).', 'timeFrame': '2 weeks and 4 weeks after the start of the treatment'}, {'measure': 'Safety based on the laboratory tests before and at the end of the treatment.', 'timeFrame': '4 weeks during the treatment period and 4 weeks following post- therapy period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patient fulfilling the Rome III criteria for IBS-C\n2. Signed informed consent at screening visit\n\nExclusion Criteria:\n\n1. Patients having significant diarrhea at least 25% of the time during the past 3 months\n2. Patients having alarm symptoms or signs\n3. Chronic diarrhea\n4. History of gastrointestinal haemorrhage, mechanical obstruction or perforation\n5. Patient with clinically relevant ECG abnormalities (prolonged QT interval)\n6. Active psychiatric disorder that would interfere with the study objectives\n7. Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient\n8. Severe hepatic, renal, cardiac, metabolic, haematological or malignant diseases (including prolactin dependent tumours) or clinically relevant deviations in laboratory values (AST/ALT greater than twice the upper limit of normal, serum creatinine \\* 2 mg/dl \\[177 µmol/l\\] according to the medical judgement of the investigator\n9. Patient with hypokalemia (serum potassium \\< 3.5 mmol/l).\n10. History of any known hypersensitivity to the ingredients of the investigational drug\n11. Pregnancy or lactation\n12. Women with childbearing potential who do not apply a medically accepted method of contraception.'}, 'identificationModule': {'nctId': 'NCT01027260', 'briefTitle': 'Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Randomized, Placebo Controlled Study on the Efficacy of Itopride HCI on Irritable Bowel in Patients of Irritable Bowel Syndrome With Constipation (IBS-C)', 'orgStudyIdInfo': {'id': 'R10-257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Itopride 50 mg', 'interventionNames': ['Drug: Itopride HCI 50 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Itopride 100 mg', 'interventionNames': ['Drug: Itopride HCI 100 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Itopride HCI 50 mg', 'type': 'DRUG', 'otherNames': ['ABT-654', 'Itopride HCI', 'Ganaton'], 'description': 'Variable dosing', 'armGroupLabels': ['Itopride 50 mg']}, {'name': 'Itopride HCI 100 mg', 'type': 'DRUG', 'otherNames': ['ABT-654', 'Itopride HCI', 'Ganaton'], 'description': 'Variable dosing', 'armGroupLabels': ['Itopride 100 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Variable dosing', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 5870', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 21441', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 6130', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Rawalpindi', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 8535', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}