Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00948818
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2009-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003248', 'term': 'Constipation'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Paul.Eng@frx.com', 'phone': '201-427-8071', 'title': 'Paul F.C. Eng Ph.D Director, Clinical Development', 'organization': 'Forest Research Institute'}, 'certainAgreement': {'otherDetails': 'All data generated in this trial will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the trial. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data for the treatment period was collected from July of 2009 to July of 2010', 'description': '803 patients were randomized to treatment. A total of 802 patients received double-blind study drug and were included in the Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Treatment Period', 'description': 'Dose-matched placebo, oral administration, once per day.', 'otherNumAtRisk': 396, 'otherNumAffected': 22, 'seriousNumAtRisk': 396, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Linaclotide - Treatment Period', 'description': 'Linaclotide 290µg, oral administration, once per day.', 'otherNumAtRisk': 406, 'otherNumAffected': 93, 'seriousNumAtRisk': 406, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo to Linaclotide - Randomized Withdrawal Period', 'description': 'Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.\n\nThis group had previously received dose-matched placebo during the 12-week randomized treatment period.', 'otherNumAtRisk': 333, 'otherNumAffected': 41, 'seriousNumAtRisk': 333, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Linaclotide to Placebo - Randomized Withdrawal Period', 'description': 'Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.\n\nThis group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period.', 'otherNumAtRisk': 154, 'otherNumAffected': 1, 'seriousNumAtRisk': 154, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Linaclotide to Linaclotide - Randomized Withdrawal Period', 'description': 'Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period', 'otherNumAtRisk': 158, 'otherNumAffected': 5, 'seriousNumAtRisk': 158, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 406, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Nonresponder', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.60', 'ciLowerLimit': '1.51', 'ciUpperLimit': '4.47', 'pValueComment': 'The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.', 'groupDescription': 'Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders.\n\nThe power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.\n\nThe AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.\n\nA CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.705', 'spread': '0.128', 'groupId': 'OG000'}, {'value': '2.272', 'spread': '0.127', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The number of CSBMs per week.', 'unitOfMeasure': 'CSBMs per Week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'PRIMARY', 'title': 'Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder', 'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.65', 'ciLowerLimit': '2.26', 'ciUpperLimit': '5.88', 'pValueComment': 'The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.', 'groupDescription': 'Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders.\n\nThe power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.\n\nA CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.\n\nAn SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'PRIMARY', 'title': 'Abdominal Pain Responder, 9 Out of 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder', 'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.91', 'pValueComment': 'The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.', 'groupDescription': 'Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders.\n\nThe power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.\n\nThe Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'PRIMARY', 'title': 'Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder', 'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.93', 'ciLowerLimit': '1.40', 'ciUpperLimit': '2.66', 'pValueComment': 'The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.', 'groupDescription': 'Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.\n\nThe power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.\n\nThe AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.\n\nA CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Spontaneous Bowl Movement (SBM) Frequency Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.130', 'spread': '.0177', 'groupId': 'OG000'}, {'value': '3.898', 'spread': '0.176', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The number of Spontaneous Bowl Movements experienced per week.', 'unitOfMeasure': 'SBMs per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Stool Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.662', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '2.071', 'spread': '0.060', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.\n\n1. = separate hard lumps like nuts \\[difficult to pass\\]\n2. = sausage shaped but lumpy\n3. = like a sausage but with cracks on surface\n4. = like a sausage or snake, smooth and soft\n5. = soft blobs with clear-cut edges \\[passed easily\\]\n6. = fluffy pieces with ragged edges, a mushy stool\n7. = watery, no solid pieces \\[entirely liquid\\]).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Severity of Straining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.651', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-1.306', 'spread': '0.042', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Straining is measured on a 5-point scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Change in Abdominal Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.129', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-1.869', 'spread': '0.093', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Change in Abdominal Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.211', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '-1.953', 'spread': '0.096', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Abdominal Discomfort is measured on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Change in Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.100', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '-1.944', 'spread': '0.099', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': 'Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder', 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': 'Abdominal Pain Responder for 6 Out of 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.\n\nThe Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}, {'type': 'SECONDARY', 'title': '12-Week Percent of Abdominal Pain-free (APF) Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'OG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.31', 'spread': '15.74', 'groupId': 'OG000'}, {'value': '9.81', 'spread': '21.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': "Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst\n\nAbdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.", 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'FG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '406'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '335'}, {'groupId': 'FG001', 'numSubjects': '312'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '94'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Patient recruitment occurred over an eight month period from July 2009 to March 2009 at 118 study sites (111 in the United States, 7 in Canada).', 'preAssignmentDetails': 'Patients went through a 14 to 21 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS). All randomized patients needed an abdominal pain score ≥ 3. One randomized patient in the Placebo arm did not receive study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'BG000'}, {'value': '406', 'groupId': 'BG001'}, {'value': '802', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral administration, once per day.'}, {'id': 'BG001', 'title': 'Linaclotide', 'description': 'Linaclotide 290µg, oral administration, once per day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '43.5', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 years to 64 years', 'categories': [{'measurements': [{'value': '370', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '757', 'groupId': 'BG002'}]}]}, {'title': '65 years and older', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '358', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '726', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '741', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 803}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2011-09-30', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2009-07-28', 'dispFirstSubmitQcDate': '2011-09-30', 'resultsFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2009-07-28', 'dispFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-19', 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.\n\nThe AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.\n\nA CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation."}, {'measure': 'Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.\n\nA CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.\n\nAn SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.'}, {'measure': 'Abdominal Pain Responder, 9 Out of 12 Weeks', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.\n\nThe Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."}, {'measure': 'Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.\n\nThe AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.\n\nA CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation."}], 'secondaryOutcomes': [{'measure': '12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The number of CSBMs per week.'}, {'measure': '12-Week Spontaneous Bowl Movement (SBM) Frequency Rate', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The number of Spontaneous Bowl Movements experienced per week.'}, {'measure': '12-Week Stool Consistency', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.\n\n1. = separate hard lumps like nuts \\[difficult to pass\\]\n2. = sausage shaped but lumpy\n3. = like a sausage but with cracks on surface\n4. = like a sausage or snake, smooth and soft\n5. = soft blobs with clear-cut edges \\[passed easily\\]\n6. = fluffy pieces with ragged edges, a mushy stool\n7. = watery, no solid pieces \\[entirely liquid\\]).'}, {'measure': '12-Week Severity of Straining', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Straining is measured on a 5-point scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount.'}, {'measure': '12-Week Change in Abdominal Pain Score', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.'}, {'measure': '12-Week Change in Abdominal Discomfort', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Abdominal Discomfort is measured on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe."'}, {'measure': '12-Week Change in Bloating', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".'}, {'measure': 'Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.'}, {'measure': 'Abdominal Pain Responder for 6 Out of 12 Weeks', 'timeFrame': 'Change from Baseline to Week 12', 'description': "A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.\n\nThe Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."}, {'measure': '12-Week Percent of Abdominal Pain-free (APF) Days', 'timeFrame': 'Change from Baseline to Week 12', 'description': "Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst\n\nAbdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Constipation', 'Linaclotide'], 'conditions': ['Irritable Bowel Syndrome Characterized by Constipation']}, 'referencesModule': {'references': [{'pmid': '24075889', 'type': 'DERIVED', 'citation': 'Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.'}, {'pmid': '23116208', 'type': 'DERIVED', 'citation': 'Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).\n\nThe primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:\n\n 1. Relieved with defecation\n 2. Onset associated with a change in frequency of stool\n 3. Onset associated with a change in form (appearance) of stool\n* Patient reports \\< 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \\> 25% of BMs\n* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)\n* Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms\n\nExclusion Criteria:\n\n* Patient has history of loose or watery stools for \\>25% of BMs\n* Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility\n* Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments'}, 'identificationModule': {'nctId': 'NCT00948818', 'briefTitle': 'Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation', 'orgStudyIdInfo': {'id': 'LIN-MD-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linaclotide', 'description': 'Linaclotide 290 micrograms', 'interventionNames': ['Drug: Linaclotide 290 micrograms']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'Linaclotide 290 micrograms', 'type': 'DRUG', 'description': 'Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study', 'armGroupLabels': ['Linaclotide']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 037', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 036', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35023', 'city': 'Hueytown', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 135', 'geoPoint': {'lat': 33.45122, 'lon': -86.99666}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 014', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 080', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 053', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 078', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 101', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative 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