Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT00706004
Status:
COMPLETED
Last Update Posted:
2011-04-18
First Post:
2008-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068238', 'term': 'Lubiprostone'}], 'ancestors': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'obriencatherinee@uams.edu', 'phone': '501-364-1828', 'title': "Catherine O'Brien", 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lubiprostone', 'description': '24 micrograms twice daily', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline period', 'categories': [{'measurements': [{'value': '9.7', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '10.8', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '8.8', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week run-in period, 2-weeks of treatment, 4-weeks of treatment', 'unitOfMeasure': 'bowel movements', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Patient Assessment of Constipation Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week run-in period, 2 weeks of treatment, 4 weeks of treatment', 'description': "The Patient Assessment of Constipation - Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient's assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Bristol Stool Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week run-in period, 2 weeks of treatment, 4 weeks of treatment', 'description': 'The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '24.0', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '24.3', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 2 weeks of treatment, 4 weeks of treatment', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Self Reported Adverse Effects at Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily'}], 'classes': [{'title': '2 weeks', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During entire study period', 'description': 'Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '137.4', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '139.2', 'spread': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '103.0', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '104.3', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Bicarb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.8', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '25.2', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum BUN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.0', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '12.7', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.6', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '17.5', 'spread': '3.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.1', 'spread': '16.7', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '23.8', 'spread': '14.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '9.3', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '150.3', 'spread': '101.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '131.8', 'spread': '83.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.3', 'spread': '15.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '25.3', 'spread': '18.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Vitamin A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.3', 'spread': '14.6', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '42.7', 'spread': '23.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'ug/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Vitamin E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.6', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '7.7', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Prealbumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.6', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '21.5', 'spread': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Serum Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lubiprostone 24 Mcg Twice Daily', 'description': 'Participants served as their own controls'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lubiprostone', 'description': '24 micrograms twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lubiprostone', 'description': '24 micrograms twice daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of subjects analyzed here is 7 as only 7 completed this pilot study.', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '5.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The number of subjects analyzed here is 7 as only 7 completed this pilot study.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of subjects analyzed here is 7 as only 7 completed this pilot study.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of subjects analyzed here is 7 as only 7 completed this pilot study.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-14', 'studyFirstSubmitDate': '2008-06-25', 'resultsFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2008-06-26', 'lastUpdatePostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-14', 'studyFirstPostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Spontaneous Bowel Movements Per Week', 'timeFrame': '2-week run-in period, 2-weeks of treatment, 4-weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Patient Assessment of Constipation Symptoms', 'timeFrame': '2-week run-in period, 2 weeks of treatment, 4 weeks of treatment', 'description': "The Patient Assessment of Constipation - Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient's assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4)."}, {'measure': 'Bristol Stool Scale Score', 'timeFrame': '2-week run-in period, 2 weeks of treatment, 4 weeks of treatment', 'description': 'The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.'}, {'measure': 'Body Mass Index', 'timeFrame': 'baseline, 2 weeks of treatment, 4 weeks of treatment'}, {'measure': 'Self Reported Adverse Effects at Each Study Visit', 'timeFrame': 'During entire study period', 'description': 'Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.'}, {'measure': 'Serum Sodium', 'timeFrame': 'baseline, 4 weeks'}, {'measure': 'Serum Chloride', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Potassium', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Bicarb', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum BUN', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Creatinine', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'AST', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'ALT', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Calcium', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Magnesium', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Phosphate', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Glucose', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Vitamin D', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Vitamin A', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Vitamin E', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Prealbumin', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'Serum Albumin', 'timeFrame': 'baseline and 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['constipation', 'cystic fibrosis', 'lubiprostone', 'Constipation in adults with cystic fibrosis'], 'conditions': ['Constipation', 'Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.', 'detailedDescription': 'Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women of all races\n* 18 years of age or older at time of enrollment\n* Diagnosis of cystic fibrosis\n* History of constipation, as defined by the Rome III criteria, OR the requirement of chronic scheduled doses of a laxative, OR a score ≥1.5 on the Patient assessment of constipation symptoms (PAC-SYM)15 survey administered during the screening visit, OR a score of less than 3 on the Bristol Stool Scale (BSS) at the screening visit.\n\nExclusion Criteria:\n\n* Current gastrointestinal (GI) obstruction\n* History of GI obstruction requiring hospitalization within six months of enrollment\n* Pregnancy or breastfeeding\n* Hypersensitivity to lubiprostone or any of its components\n* Serum creatinine \\>1.8 mg/dL at last annual visit\n* Clinically significant liver disease, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3X upper limit of normal\n* History of frequent hospital admissions for CF exacerbations (≥4 in the last 6 months)\n* Currently registered on a lung transplant waiting list\n* Women of capable of child-bearing who either refuse a pregnancy test, or are incapable or unwilling to use contraception during the protocol, or both.\n* Any other condition, in the opinion of the investigators, that interferes with the ability of the participant to comply with study requirements, confers significant risk to the participant, or limits the ability of the participant to complete the study'}, 'identificationModule': {'nctId': 'NCT00706004', 'briefTitle': 'Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '76992'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lubiprostone', 'type': 'DRUG', 'otherNames': ['Brand name: Amitiza'], 'description': 'lubiprostone 24 microgram capsule taken twice daily for 4 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': "Catherine E. O'Brien, Pharm.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda Pharmaceuticals North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': "Catherine E. O'Brien", 'oldOrganization': 'University of Arkansas for Medical Sciences'}}}}