Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT01532518
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2012-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C107754', 'term': 'MEN 11420'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acapriati@menarini-ricerche.it', 'phone': '+39 05556809990', 'title': 'Dr. Angela Capriati', 'organization': 'Menarini Ricerche'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study.\n\nThere IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.\n\nThe results of the study cannot be submitted for presentation, abstract, poster exhibition, or publication by the investigator until Menarini Ricerche S.p.A.\n\nhas reviewed/commented and agreed to any publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study performed in a small number of subjects.'}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'description': 'Analysed for the Safety Population (all patients who received the study drug) The analysis is by treatment - Each infant was treated with two out of three ascending dose (0.1, 0.5 or 1.0 mg/kg), therefore counted in more than one dose level.', 'eventGroups': [{'id': 'EG000', 'title': 'High Dose Level (1.0 mg/Kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 1.0mg/kg (Subjects who took Nepadutant 1.0 mg/dl for the additional 7 days - coming from Nepadutant 0.1 mg/kg and 0.5 mg/kg)\n\nNepadutant: Nepadutant oral solution', 'otherNumAtRisk': 21, 'otherNumAffected': 12, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Medium Dose Level (0.5mg/Kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 0.5 mg/kg (subjects who took Nepadutant 0.5 mg/dl for the first 7 days AND subjects who took Nepadutant 0.5 mg/dl for the additional 7 days - coming from Neapdutant 0.1 mg/kg)\n\nNepadutant: Nepadutant oral solution', 'otherNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Dose Level(0.1mg/Kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 0.1 mg/kg (subjects who took Nepadutant 0.1mg/dl for the first 7 days)\n\nNepadutant: Nepadutant oral solution', 'otherNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Screaming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Upper respiratory atract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Seborrhoic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}], 'seriousEvents': [{'term': 'Hospitalisation for investigation for suspected seizures', 'notes': '10 wks-old male-familiar history of seizure disorders.It started 6days after the last drug intake (nepadutant 0.1mg/kg early terminate after 3drug intakes).It reported as "moderate","not related" to nepadutant by investigator. It resolved: no sequel.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}, {'term': 'Laryngeal Edema-post intubation', 'notes': 'Prolongation of hospitalization due to post-intubation laryngeal edema in a 22wks-old female.It started 4days after the end of the 2weeks of treatment:it reported as "moderate","not related" to the treatment by investigators.It resolved:no sequel.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG002', 'title': 'Cohort 1', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.8', 'spread': '9.55', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '5.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (V2) and end of first week of treatment (V3)', 'description': 'Results obtained at V2 serve as baseline values for the assessment of effects at V3 (i.e. end of first week of treatment).\n\nInfant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Infants with feeding intolerance who received at least 1 dose of nepadutant. In the 3rd cohort 1 subject didn't report I-GERQ-R score at randomization. In the 1rst cohort 1 patient early terminated after V2."}, {'type': 'PRIMARY', 'title': 'The Absolute Differences of I-GERQ-R Total Score at V4 (End of 2nd Week of Treatment) Respect to V3 (End of 1st Week of Treatment).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG002', 'title': 'Cohort 1', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.2', 'spread': '5.54', 'groupId': 'OG000'}, {'value': '-11.9', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '6.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'V3 (end of 1st week of treatment) and V4 (end of 2nd week of treatment)', 'description': 'The results obtained at V3 are used as baseline for the second week treatment period (V4).\n\nInfant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.', 'unitOfMeasure': 'Score as sum of units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Infants with feeding intolerance who received at least 1 dose of nepadutant. In the 3rd cohort 1 subject didn't report I-GERQ-R score at randomization. In the 1rst cohort 1 patient early terminated after V2."}, {'type': 'PRIMARY', 'title': 'The Absolute Differences of I-GERQ-R Total Score at V5 (Follow-up) Respect to V2 (Baseline).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG002', 'title': 'Cohort 1', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-11.1', 'spread': '6.78', 'groupId': 'OG001'}, {'value': '-9.8', 'spread': '7.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (V2) and follow up 2 weeks after the last administered dose (V5)', 'description': 'Results obtained at V2 serve as baseline values for follow-up assessment 2 weeks after the last administered dose (V5) Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.', 'unitOfMeasure': 'Score as sum of units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Infants with feeding intolerance who received at least 1 dose of nepadutant. In the 3rd cohort 1 subject didn't report I-GERQ-R score at randomization. In the 1rst cohort 1 patient early terminated after V2."}, {'type': 'PRIMARY', 'title': 'I-GERQ-R Score Changes vs Baseline (Visit 2) by First Dose Level (0.1mg/kg and 0.5mg/kg).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Level (0.1mg/kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 0.1mg/kg'}, {'id': 'OG001', 'title': 'Medium Dose Level 0.5mg/kg', 'description': 'Subjects who received at least 1 dose of nepadutant 0.5mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.8', 'spread': '7.31', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (V2) and end of 1st week of treatment(V3)', 'description': 'Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs baseline (Visit 2) by first dose level (0.1mg/kg and 0.5mg/kg). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects with feeding intolerance who received at least 1 dose of nepadutant (first dose level 0.1mg/kg and 0.5 mg/kg).\n\nOne subject in the 3rd cohort didn't report I-GERQ-R score at V2."}, {'type': 'PRIMARY', 'title': 'I-GERQ-R Score Changes vs Visit 3 by Second Dose Level (0.5mg/kg and 1mg/kg).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medium Dose Level (0.5mg/kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 0.5mg/kg'}, {'id': 'OG001', 'title': 'High Dose Level 1mg/kg', 'description': 'Subjects who received at least 1 dose of nepadutant 1mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '4.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of first week of treatment (V3) and end of second week of treatment (V4)', 'description': 'Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs Visit 3 by second dose level (0.5mg/kg and 1mg/kg).\n\nInfant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.', 'unitOfMeasure': 'Score as sum of units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with feeding intolerance who received at least 1 dose of nepadutant (second dose level 0.5mg/kg and 1 mg/kg)\n\n1 subject in the first cohort early terminated after V2'}, {'type': 'SECONDARY', 'title': 'Incidence and Severity of AEs_ Number of Adverse Events by Treatment Dose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Level (1.0 mg/Kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 1.0mg/kg (Subjects who took Nepadutant 1.0 mg/dl for the additional 7 days - coming from Nepadutant 0.1 mg/kg and 0.5 mg/kg)\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG001', 'title': 'Medium Dose Level (0.5mg/Kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 0.5 mg/kg (subjects who took Nepadutant 0.5 mg/dl for the first 7 days AND subjects who took Nepadutant 0.5 mg/dl for the additional 7 days - coming from Neapdutant 0.1 mg/kg)\n\nNepadutant: Nepadutant oral solution'}, {'id': 'OG002', 'title': 'Low Dose Level(0.1mg/Kg)', 'description': 'Subjects who received at least 1 dose of nepadutant 0.1 mg/kg (subjects who took Nepadutant 0.1mg/dl for the first 7 days)\n\nNepadutant: Nepadutant oral solution'}], 'classes': [{'title': 'gastrointestinal disorder', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'General disorders and administration site conditio', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory, thoracic and medistinal disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 4 weeks', 'description': 'The analysis is by treatment - Each infant was treated with two out of three ascending dose (0.1, 0.5 or 1.0 mg/kg), therefore counted in more than one dose level.', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one administration of study treatment including dose tolerability test (safety population)'}, {'type': 'SECONDARY', 'title': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort1'}, {'id': 'OG001', 'title': 'Cohort 2'}, {'id': 'OG002', 'title': 'Cohort 3'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '0.919', 'upperLimit': '1.57'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.59'}, {'value': '1.64', 'groupId': 'OG002', 'lowerLimit': '1.39', 'upperLimit': '1.89'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'The population pharmacokinetic analyses is presented. PopPK Clearance estimated with a one compartment model with first order absorption and elimination.', 'unitOfMeasure': 'L/h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At visit 2, samples from 12 subjects in 0.1 mg/kg and from 15 subjects in 0.5 mg/kg.\n\nAt visit 3\\*, 4\\*: samples from 15 subjects in 0.1 - 0.5 mg/kg cohort, from 5 in 0.5 - 1 mg/kg cohort and from 6 in 0.1 - 1 mg/kg cohort.\n\n\\*N=26 instead of 27 as one patient early terminated the study'}, {'type': 'SECONDARY', 'title': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1, 2, and 3', 'description': 'Overall population participating to the study for PoP PK analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'comment': 'no inter-individual variability was estimated, the value for all cohorts corresponds to the typical value.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'PopPK Volume estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'At visit 2, samples from 6 subjects in Cohort 1 at 0.1mg/kg; 6 subjects in Cohort 3 at 0,1 mg/kg; 15 subjects in Cohort 2 at 0.5 mg/kg.\n\nAt visit 3\\*, 4\\*: samples from 5 subjects in Cohort 1 (0.1 - 0.5 mg/kg), 15 subjects in Cohort 2 (0.5 - 1 mg/kg) and 6 subjects in Cohort 3 (0.1 - 1 mg/kg).'}, {'type': 'SECONDARY', 'title': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1, 2 and 3', 'description': 'Data from the 3 cohorts used for PoP PK analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '206', 'comment': 'no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'The population pharmacokinetic analyses is presented. PopPK Ka estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value.', 'unitOfMeasure': '1/h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'At visit 2, samples from 6 subjects in Cohort 1 at 0.1mg/kg; 6 subjects in Cohort 3 at 0,1 mg/kg; 15 subjects in Cohort 2 at 0.5 mg/kg.\n\nAt visit 3\\*, 4\\*: samples from 5 subjects in Cohort 1 (0.1 - 0.5 mg/kg), 15 subjects in Cohort 2 (0.5 - 1 mg/kg) and 6 subjects in Cohort 3 (0.1 - 1 mg/kg).'}, {'type': 'SECONDARY', 'title': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1'}, {'id': 'OG001', 'title': 'Cohort 2'}, {'id': 'OG002', 'title': 'Cohort 3'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0275', 'groupId': 'OG000', 'lowerLimit': '0.0199', 'upperLimit': '0.0352'}, {'value': '0.0342', 'groupId': 'OG001', 'lowerLimit': '0.0250', 'upperLimit': '0.0433'}, {'value': '0.0346', 'groupId': 'OG002', 'lowerLimit': '0.0346', 'upperLimit': '0.0377'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'The population pharmacokinetic analyses is presented. The PopPK parameter fraction of the dose absorbed (F1) is estimated with a one compartment model with first order absorption and elimination.The results are presented fraction of the absorbed dose with 95% CI of the parameter estimate value', 'unitOfMeasure': 'fraction of dose absorbed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At visit 2, samples from 6 subjects in Cohort 1 at 0.1mg/kg; 6 subjects in Cohort 3 at 0,1 mg/kg; 15 subjects in Cohort 2 at 0.5 mg/kg.\n\nAt visit 3\\*, 4\\*: samples from 5 subjects in Cohort 1 (0.1 - 0.5 mg/kg), 15 subjects in Cohort 2 (0.5 - 1 mg/kg) and 6 subjects in Cohort 3 (0.1 - 1 mg/kg).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 3', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'FG002', 'title': 'Cohort 1', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 3', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'BG002', 'title': 'Cohort 1', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days\n\nNepadutant: Nepadutant oral solution'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.52', 'spread': '4.281', 'groupId': 'BG000'}, {'value': '13.62', 'spread': '6.468', 'groupId': 'BG001'}, {'value': '14.27', 'spread': '6.559', 'groupId': 'BG002'}, {'value': '13.52', 'spread': '5.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age is in weeks (PGA: post gestational age)', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'particpants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '5.323', 'spread': '0.9085', 'groupId': 'BG000'}, {'value': '5.623', 'spread': '1.1045', 'groupId': 'BG001'}, {'value': '5.708', 'spread': '1.764', 'groupId': 'BG002'}, {'value': '5.576', 'spread': '1.1975', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'I-GERQ-R total score', 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '19', 'spread': '6.32', 'groupId': 'BG001'}, {'value': '21.8', 'spread': '9.91', 'groupId': 'BG002'}, {'value': '20.8', 'spread': '7.22', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Infants with Feeding Intolerance'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2012-01-25', 'resultsFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2012-02-09', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-12', 'studyFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2).', 'timeFrame': 'Baseline (V2) and end of first week of treatment (V3)', 'description': 'Results obtained at V2 serve as baseline values for the assessment of effects at V3 (i.e. end of first week of treatment).\n\nInfant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.'}, {'measure': 'The Absolute Differences of I-GERQ-R Total Score at V4 (End of 2nd Week of Treatment) Respect to V3 (End of 1st Week of Treatment).', 'timeFrame': 'V3 (end of 1st week of treatment) and V4 (end of 2nd week of treatment)', 'description': 'The results obtained at V3 are used as baseline for the second week treatment period (V4).\n\nInfant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.'}, {'measure': 'The Absolute Differences of I-GERQ-R Total Score at V5 (Follow-up) Respect to V2 (Baseline).', 'timeFrame': 'Baseline (V2) and follow up 2 weeks after the last administered dose (V5)', 'description': 'Results obtained at V2 serve as baseline values for follow-up assessment 2 weeks after the last administered dose (V5) Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.'}, {'measure': 'I-GERQ-R Score Changes vs Baseline (Visit 2) by First Dose Level (0.1mg/kg and 0.5mg/kg).', 'timeFrame': 'Baseline (V2) and end of 1st week of treatment(V3)', 'description': 'Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs baseline (Visit 2) by first dose level (0.1mg/kg and 0.5mg/kg). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.'}, {'measure': 'I-GERQ-R Score Changes vs Visit 3 by Second Dose Level (0.5mg/kg and 1mg/kg).', 'timeFrame': 'end of first week of treatment (V3) and end of second week of treatment (V4)', 'description': 'Change in Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Score. Assessing the I-GERQ-R score changes vs Visit 3 by second dose level (0.5mg/kg and 1mg/kg).\n\nInfant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \\>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and arching. Questions with 4 possible options have a score ranging from 0 to 3; questions with 5 possible options have a score ranging from 0 to 4.\n\nThe scores of each item are summed, so the total score is presented.'}], 'secondaryOutcomes': [{'measure': 'Incidence and Severity of AEs_ Number of Adverse Events by Treatment Dose Level', 'timeFrame': 'up to 4 weeks', 'description': 'The analysis is by treatment - Each infant was treated with two out of three ascending dose (0.1, 0.5 or 1.0 mg/kg), therefore counted in more than one dose level.'}, {'measure': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'The population pharmacokinetic analyses is presented. PopPK Clearance estimated with a one compartment model with first order absorption and elimination.'}, {'measure': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'PopPK Volume estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value.'}, {'measure': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'The population pharmacokinetic analyses is presented. PopPK Ka estimated with a one compartment model with first order absorption and elimination. NOTE: for this measure, no inter-individual variability was estimated, therefore the value for each cohort corresponds to the typical value.'}, {'measure': 'A Population Pharmacokinetic Analysis to Characterize the Plasma Concentration-time Course for Nepadutant in Infant With Colics From NIC-04', 'timeFrame': '0.5, 1, 2, 3 hours post Single Dose and 24 hours post Repeated Dose', 'description': 'The population pharmacokinetic analyses is presented. The PopPK parameter fraction of the dose absorbed (F1) is estimated with a one compartment model with first order absorption and elimination.The results are presented fraction of the absorbed dose with 95% CI of the parameter estimate value'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Feeding intolerance', 'Infant', 'tachykinin antagonist', 'Infant colic', 'Nepadutant'], 'conditions': ['Colic']}, 'descriptionModule': {'briefSummary': 'The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.', 'detailedDescription': 'Feeding intolerance is a transient neuro-developmental phenomenon affecting 25% to 40% of infant and toddler, with a peak at 6 weeks of age. Feeding problems include mainly vomiting, slow feeding, refusal to eat and colic.\n\nCurrent non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs and antiacids) are largely unsatisfactory.\n\nNepadutant is postulated to have a therapeutic effect in infant colic since it reverts exaggerated intestinal motility and sensitivity induced by different stimuli through the activation of neurokinin-2 receptors, without interferring on the on physiological gastrointestinal transit.\n\nThis phase IIa study is designed to test in each participant infant two out of three oral doses of nepadutant in order to measure its blood levels, safety and efficacy with each dose level to be given for 7 concecutive days.\n\nThe experimental clinical phase encompasses the following periods:\n\n* Screening period (no study medication), lasting approximately 7 days prior to randomization\n* Treatment period, lasting fourteen days (7 days fore each dose)with once daily administration\n* A safety follow-up visit, approximately four weeks after start of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with a clinical diagnosis of feeding intolerance.\n* Age ≤ 6 months at the enrolment.\n* Normal growth.\n* Infants who can refrain from use of erythromycin, metoclopramide, antihistaminic drug, proton pump inhibitors (PPIs), antacids, antimuscarinic drugs, simethicone and dimethicone from 1 week prior randomization until end of study.\n\nExclusion Criteria:\n\n* Any clinically relevant event (excluding those relevant to the condition under study) which has occurred within one week prior to randomization.\n* Any pharmacological treatment starting within one week prior to randomization.\n* Infants for whom a change in the diet (i.e. weaning) has been performed within one week prior to randomization or is planned during the study period.'}, 'identificationModule': {'nctId': 'NCT01532518', 'briefTitle': 'Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Menarini Group'}, 'officialTitle': 'A Multicenter, Open Label, Ascending 7 Day-Repeated Dose Study to Investigate Efficacy, Safety and Pharmacokinetics of Nepadutant In Infants With Feeding Intolerance', 'orgStudyIdInfo': {'id': 'NIC-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days', 'interventionNames': ['Drug: Nepadutant']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days', 'interventionNames': ['Drug: Nepadutant']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days', 'interventionNames': ['Drug: Nepadutant']}], 'interventions': [{'name': 'Nepadutant', 'type': 'DRUG', 'otherNames': ['MEN 11420'], 'description': 'Nepadutant oral solution', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Center for Digestive Healthcare", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kosair Charities Pediatric Clinical Research Unit / University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '12207', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': "The University of Toledo College of Medicine\\The Toledo Children's Hospital", 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Jeffrey L Blumer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Toledo Medical Center 3000 Arlington Avenue, Toledo OH 43614 USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menarini Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}