Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT00637806
Status:
TERMINATED
Last Update Posted:
2016-05-02
First Post:
2008-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000855', 'term': 'Anorexia'}, {'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D013851', 'term': 'Thinness'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019290', 'term': 'Megestrol Acetate'}], 'ancestors': [{'id': 'D008535', 'term': 'Megestrol'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kirby.todd@endo.com', 'phone': '(484) 216-6491', 'title': 'M. Todd Kirby, PhD', 'organization': 'Endo Pharmaceuticals Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 98 days (from informed consent through 7 days following the last dose of study drug or up until the last protocol-specified study visit, whichever occurred later)', 'eventGroups': [{'id': 'EG000', 'title': 'DB MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DB MA-CS 300 mg/Day', 'description': 'MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DB Placebo', 'description': 'Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'OL MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'seriousEvents': [{'term': 'Accident at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG001', 'title': 'DB MA-CS 300 mg/Day', 'description': 'MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG002', 'title': 'DB Placebo', 'description': 'Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase'}], 'timeFrame': '8 weeks', 'description': "The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.", 'reportingStatus': 'POSTED', 'populationDescription': 'Results not analyzed due to early termination of the study'}, {'type': 'SECONDARY', 'title': 'Change in Weight Over the Course of the 8-week Double-blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG001', 'title': 'DB MA-CS 300 mg/Day', 'description': 'MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG002', 'title': 'DB Placebo', 'description': 'Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase'}], 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 6, and 8', 'reportingStatus': 'POSTED', 'populationDescription': 'Results not analyzed due to early termination of the study'}, {'type': 'SECONDARY', 'title': 'Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG001', 'title': 'DB MA-CS 300 mg/Day', 'description': 'MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG002', 'title': 'DB Placebo', 'description': 'Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase'}], 'timeFrame': 'Baseline, Week 4 and Week 8', 'reportingStatus': 'POSTED', 'populationDescription': 'Results not analyzed due to early termination of the study'}, {'type': 'SECONDARY', 'title': 'Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG001', 'title': 'DB MA-CS 300 mg/Day', 'description': 'MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'OG002', 'title': 'DB Placebo', 'description': 'Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase'}], 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 6 and 8', 'description': 'Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food', 'reportingStatus': 'POSTED', 'populationDescription': 'Results not analyzed due to early termination of the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB MA-CS 550 mg/Day', 'description': 'Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase'}, {'id': 'FG001', 'title': 'DB MA-CS 300 mg/Day', 'description': 'MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'FG002', 'title': 'DB Placebo', 'description': 'Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase'}, {'id': 'FG003', 'title': 'OL MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase'}], 'periods': [{'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'After screening, eligible subjects were randomized to treatment in the double-blind phase. After completing the double-blind phase or discontinuing due to specific weight loss criteria, eligible subjects could enter an open-label extension phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DB MA-CS 550 mg/Day', 'description': 'MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'BG001', 'title': 'DB MA-CS 300 mg/Day', 'description': 'MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase'}, {'id': 'BG002', 'title': 'DB Placebo', 'description': 'Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects who received at least 1 dose of study medication and who had at least 1 on-therapy safety assessment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Difficulty finding the required patient population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2008-03-11', 'resultsFirstSubmitDate': '2016-01-29', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-31', 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase', 'timeFrame': '8 weeks', 'description': "The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value."}], 'secondaryOutcomes': [{'measure': 'Change in Weight Over the Course of the 8-week Double-blind Phase', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 6, and 8'}, {'measure': 'Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline', 'timeFrame': 'Baseline, Week 4 and Week 8'}, {'measure': 'Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale', 'timeFrame': 'Baseline, Weeks 1, 2, 3, 4, 6 and 8', 'description': 'Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Megestrol acetate', 'Anorexia', 'Cachexia', 'Cancer', 'Unintended weight loss', 'Body weight', 'Appetite', 'Megace ES'], 'conditions': ['Anorexia', 'Cachexia', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer of multiple types in stage II, III, or IV and not a candidate for chemotherapy; but may have been receiving radiation therapy\n* Fair, poor, or very poor appetite\n* Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at least 10% over prior 6 months)\n* Weight loss perceived to be associated with diminished appetite\n* Eastern Cooperative Oncology Group Performance score of 0, 1, or 2\n* Life expectancy greater than 3 months\n* Alert and mentally competent to complete study assessments\n* Women of child-bearing potential required to use an adequate and reliable method of contraception. Post-menopausal women have to have been so for at least 1 year\n* Screening laboratory values must not be clinically significant (some exceptions per protocol)\n\nExclusion Criteria:\n\n* Brain, or head and neck tumors that may interfere with food consumption\n* AIDS-related wasting\n* Radiation therapy to head and neck, abdomen, or pelvis within past 6 weeks, or for whom radiation therapy is anticipated during the study such that the result may interfere with food consumption\n* Presence of conditions that interfere with oral intake or ability to swallow\n* Absence of normally functioning gut\n* Known mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome\n* Intractable or frequent vomiting\n* Clinically significant diarrhea\n* History of thromboembolic events, or on long-term anticoagulation for thromboembolism\n* Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism\n* Poorly controlled hypertension or congestive heart failure\n* Pregnant/lactating females, or planning on becoming pregnant\n* Use of appetite stimulants within past 30 days\n* Use of parenteral nutrition or tube feedings within past 1 week\n* Chronic use of steroids within past 3 months (intermittent short-term use allowed)\n* Current use of illicit substances\n* Allergy, hypersensitivity, or other contraindication to megestrol acetate'}, 'identificationModule': {'nctId': 'NCT00637806', 'briefTitle': 'Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Par Pharmaceutical, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-associated Anorexia in Subjects With Cancer of Multiple Types', 'orgStudyIdInfo': {'id': '100.2.C.005 TRANSFERRED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Megestrol acetate concentrated suspension 110 mg/mL', 'interventionNames': ['Drug: Megestrol acetate concentrated suspension 110 mg/mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Megestrol acetate concentrated suspension 60 mg/mL', 'interventionNames': ['Drug: Megestrol acetate concentrated suspension 60 mg/mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Megestrol acetate concentrated suspension 110 mg/mL', 'type': 'DRUG', 'otherNames': ['Megace ES'], 'description': 'Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase', 'armGroupLabels': ['1']}, {'name': 'Megestrol acetate concentrated suspension 60 mg/mL', 'type': 'DRUG', 'otherNames': ['Megace ES'], 'description': 'Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral suspension, 5 mL once daily', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '28731', 'city': 'Flat Rock', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Four Seasons Hospice and Paliative Care', 'geoPoint': {'lat': 35.27123, 'lon': -82.44151}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summit Oncology Associates, Inc.', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Lynn D Kramer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Par Pharmaceutical, Inc.'}, {'name': 'Janet Bull, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Four Seasons Hospice and Paliative Care'}, {'name': 'Veena Charu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pacific Cancer Medical Center, Inc.'}, {'name': 'Bart Frizzell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University, Dept of Radiation Oncology'}, {'name': 'Mehool Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summit Oncology Associates, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Par Pharmaceutical, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PRA Health Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}