Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT01559012
Status:
COMPLETED
Last Update Posted:
2014-04-30
First Post:
2012-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006939', 'term': 'Hyperemesis Gravidarum'}], 'ancestors': [{'id': 'D048968', 'term': 'Morning Sickness'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amaina@cittadellasalute.to.it', 'phone': '0039011313', 'title': 'Dr. Aldo Maina M.D. Obstetric Medicine', 'phoneExt': '5735', 'organization': "Città della Salute e della Scienza Ospedale Sant'Anna. Servizio di Medicina Interna"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Efficacy and safety issues are represented by maternal exposure in a critical period for organogenesis and hypotensive effect of the drug.\n\nFindings based on a very limited number of women limit the reliability of results'}}, 'adverseEventsModule': {'timeFrame': '10 days of hospital stay', 'description': 'For 5 days the patient received TD clonidine, the other 5 days received placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Clonidine', 'description': 'patients are treated with transdermal clonidine patch 5 mg for 5 days', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'patients are treated with placebo (sham patch) for 5 days', 'otherNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Itching', 'notes': 'Itching was reported at day 1 on site of application of sham patch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PUQE Score for Assessment of Severity in Hyperemesis Gravidarum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'Six patients are treated with TD clonidine first for 5 days then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.\n\nThe allocation order for every patient is randomized.\n\nEvery patient is the comparison as to herself'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Six patients are treated with TD clonidine first,for 5 days, then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.\n\nThe allocation order for every patient is randomized\n\nEvery patient is the comparison as to herself'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '5.5-7.11', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '7.1'}, {'value': '8.5', 'spread': '7.3-9.3', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '9.3'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '1.05', 'ciUpperLimit': '3.32', 'pValueComment': 'A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \\< 0.01 and a beta \\> 0.90.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.7', 'groupDescription': 'This is an analysis between groups of intervention clonidine versus placebo. Statistical significance was assessed by the use of Mann-Whitney U test P \\< 0.05 was defined as statistically significant . Data are presented as mean + SD.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistical significance was assessed by the use of Mann-Whitney U test. P \\< 0.05 was defined as statistically significant', 'testedNonInferiority': False}, {'pValue': '<0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'within patient variation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '0.43', 'ciUpperLimit': '3.24', 'groupDescription': 'This is a within patient variation between clonidine and placebo. Statistical significance was assessed by the use of Mann-Whitney U test P \\< 0.05 was defined as statistically significant . Data are presented as mean +/- Standard Deviation (SD).', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \\< 0.01'}], 'paramType': 'MEAN', 'timeFrame': 'Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.', 'description': 'PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy.\n\nIt is composed of three items; every item has a score from 1 (best) to 5 (worst).\n\nThe sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A sample size calculation for crossover studies using a model available on line (MGH Mallinckrodt General Clinical Research Center - Harvard Medical School) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \\< 0.01 and a beta \\> 0.90.'}, {'type': 'PRIMARY', 'title': 'VAS Score for Assessment of Severity in Hyperemesis Gravidarum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days\n\nClonidine : transdermal clonidine patch 5 mg q. 5 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days\n\nClonidine : transdermal clonidine patch 5 mg q. 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '26'}, {'value': '29', 'spread': '2.58', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '32'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '1.78', 'ciUpperLimit': '11.5', 'groupDescription': 'Analysis within groups clonidine versus placebo. Statistical significance was assessed by the use of Mann-Whitney U test P \\< 0.05 was defined as statistically significant . Data are presented as mean + SD. .', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'within patient variation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '2.17', 'ciUpperLimit': '12.83', 'groupDescription': 'Analysis within-patient. Statistical significance was assessed by the use of Mann-Whitney U test P \\< 0.05 was defined as statistically significant . Data are presented as mean + SD.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A sample size modeling for crossover studies (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \\< 0.01'}], 'paramType': 'MEAN', 'timeFrame': 'Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.', 'description': 'VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Morning Urine Ketonuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round\n\nAllocation order randomized'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round\n\nAllocation order randomized'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.18'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.47'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of percentage of positivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.47', 'groupDescription': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round\n\nAllocation order randomized', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days', 'description': 'Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting', 'unitOfMeasure': 'Proportion of person-days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round\n\nClonidine : transdermal clonidine patch 5 mg q. 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '2.9'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '3.0'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mean values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.57', 'groupDescription': 'Statistical significance was assessed by the use of Mann-Whitney U test P \\< 0.05 was defined as statistically significant . Data are presented as mean + SD. .', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days', 'description': 'The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis.\n\nAll patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms.', 'unitOfMeasure': 'daily doses of antiemetics', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '0.54'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.36'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'days off-therapy %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29', 'groupDescription': 'Statistical significance was assessed by the use of Mann-Whitney U test P \\< 0.05 was defined as statistically significant . Data are presented as mean + SD. .', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days', 'description': 'if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.', 'unitOfMeasure': 'Proportion of person-days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at 10 days since start of treatment', 'description': 'the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'no determination of sample size'}, {'type': 'SECONDARY', 'title': 'Pregnancy Outcome Measures: Birth Weight.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mean Birth Weight of 12 Patients', 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round\n\nAllocation order randomized'}], 'classes': [{'categories': [{'measurements': [{'value': '3312', 'groupId': 'OG000', 'lowerLimit': '2510', 'upperLimit': '4180'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at delivery', 'description': 'Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.', 'unitOfMeasure': 'grams', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'no determination of sample size Recording for safety issue'}, {'type': 'SECONDARY', 'title': 'Newborn Outcome Measure: APGAR Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "APGAR Score at 1'", 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round'}, {'id': 'OG001', 'title': "APGAR Score at 5'", 'description': 'All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '9'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 1 minute and at 5 minutes after delivery', 'description': "The APGAR score is the most common indicator of neonatal status immediately after delivery.\n\nThe test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's:\n\nBreathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'APGAR score of newborns at 1 minute and at 5 minutes'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'systolic blood pressure was recorded during clonidine treatment cycle'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'systolic blood pressure was recorded during placebo cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '94'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6', 'ciLowerLimit': '0.9', 'ciUpperLimit': '10.9', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine', 'description': 'diastolic blood pressure was recorded every day during clonidine treatment cycle'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'diastolic blood pressure was recorded every day during placebo cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '60'}, {'value': '61', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '63'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '6.3', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clonidine First - Placebo Second', 'description': 'in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days\n\nClonidine : transdermal clonidine patch 5 mg q. 5 days'}, {'id': 'FG001', 'title': 'Placebo First - Clonidine Second', 'description': 'in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days\n\nClonidine : transdermal clonidine patch 5 mg q. 5 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'comment': '1 more patient added to randomization list to reach the pre-assignment number of treated patients', 'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'comment': 'Patient N. 2 withdrew from study for alleged side effects at day 1 of placebo cycle.', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients admitted to hospital for severe hyperemesis (HG) March - December 2012', 'preAssignmentDetails': 'The crossover study design allows to compare in the same patient the response to different treatment schedules.\n\nThe assumption is that the condition treated is not changing over the time of observation.\n\nThe reported evidence in literature is that severe HG does not spontaneously improve till 14th week.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clonidine First - Placebo Second', 'description': 'in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days\n\nClonidine : transdermal clonidine patch 5 mg q. 5 days'}, {'id': 'BG001', 'title': 'Placebo First - Clonidine Second', 'description': 'in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days\n\nClonidine : transdermal clonidine patch 5 mg q. 5 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '5.46', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '5.99', 'groupId': 'BG001'}, {'value': '32.1', 'spread': '5.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline biophysical and demographic data were reported:\n\nage, race, ethnicity, parity, HG in previous pregnancy, smoking, BMI, weight loss, concurrent diseases, concurrent treatment,gestational age at start of symptoms, gestational age at enrollment, PUQE score at enrollment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-31', 'studyFirstSubmitDate': '2012-03-12', 'resultsFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2012-03-18', 'lastUpdatePostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-31', 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PUQE Score for Assessment of Severity in Hyperemesis Gravidarum', 'timeFrame': 'Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.', 'description': 'PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy.\n\nIt is composed of three items; every item has a score from 1 (best) to 5 (worst).\n\nThe sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.'}, {'measure': 'VAS Score for Assessment of Severity in Hyperemesis Gravidarum', 'timeFrame': 'Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.', 'description': 'VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.'}], 'secondaryOutcomes': [{'measure': 'Morning Urine Ketonuria', 'timeFrame': 'participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days', 'description': 'Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting'}, {'measure': 'Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.', 'timeFrame': 'participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days', 'description': 'The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis.\n\nAll patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms.'}, {'measure': 'Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only', 'timeFrame': 'participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days', 'description': 'if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.'}, {'measure': 'Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.', 'timeFrame': 'at 10 days since start of treatment', 'description': 'the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective'}, {'measure': 'Pregnancy Outcome Measures: Birth Weight.', 'timeFrame': 'at delivery', 'description': 'Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.'}, {'measure': 'Newborn Outcome Measure: APGAR Score.', 'timeFrame': 'at 1 minute and at 5 minutes after delivery', 'description': "The APGAR score is the most common indicator of neonatal status immediately after delivery.\n\nThe test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's:\n\nBreathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth."}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '10 days', 'description': 'Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '10 days', 'description': 'Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperemesis Gravidarum', 'treatment', 'transdermal clonidine'], 'conditions': ['Hyperemesis Gravidarum']}, 'referencesModule': {'references': [{'pmid': '24684734', 'type': 'DERIVED', 'citation': 'Maina A, Arrotta M, Cicogna L, Donvito V, Mischinelli M, Todros T, Rivolo S. Transdermal clonidine in the treatment of severe hyperemesis. A pilot randomised control trial: CLONEMESI. BJOG. 2014 Nov;121(12):1556-62. doi: 10.1111/1471-0528.12757. Epub 2014 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover design.', 'detailedDescription': 'Setting. The trial is performed at a single hospital setting after admission of patients.\n\nEthics. The study has been approved by our local Ethics Committee and women are requested to sign an informed consent. No pharmaceutical company is involved in any phases of the trial including protocol design, study conduction, coordination and monitoring, data handling and analysis.\n\nRandomization. The patients are allocated to a random list to receive first placebo and then TD clonidine or the other way round.\n\nBlinding. Neither the patients nor their attending caregivers know the order of administration . The outcome assessors are blinded as well.\n\nTreatment.The patients are randomly treated with and without TD clonidine for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, metoclopramide, ondansetron) and anti- reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis. All patients receive intravenous hydration and supplementation with thiamine.\n\nAssessment. Physical condition of patients are assessed daily: blood pressure (lying and standing), body weight, morning ketonuria. Two different clinical self administered scores as PUQE (Pregnancy Unique Quantification of Emesis) and VAS (Visual Analogue Scale) are employed to check daily the intensity of symptoms and the sense of wellbeing. The consumption of antiemetic and anti-reflux drugs administered in the two periods is monitored .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 6-12 weeks and a major grade of HG clinical severity defined as follows:\n* a PUQE score index ≥ 13 associated to one or more of the following conditions:\n* weight loss \\> 5% of pregravidic weight,\n* electrolyte disturbances,\n* dehydration,\n* duration of symptoms \\> 10 days ,\n* inadequate food and drink intake\n\nExclusion Criteria:\n\n* Language barrier.'}, 'identificationModule': {'nctId': 'NCT01559012', 'acronym': 'CLONEMESI', 'briefTitle': 'Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'The CLONEMESI Study: a Randomized Placebo-controlled Study With Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum.', 'orgStudyIdInfo': {'id': 'Registro CE 409 det. 163/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'clonidine first - placebo second', 'description': 'in this group patients are treated with transdermal clonidine first for 5 days then switch to placebo for 5 days', 'interventionNames': ['Drug: Clonidine']}, {'type': 'OTHER', 'label': 'placebo first - clonidine second', 'description': 'in this group patients are treated with placebo first for 5 days then with transdermal clonidine for next 5 days', 'interventionNames': ['Drug: Clonidine']}], 'interventions': [{'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['Catapresan TTS 2 transdermal patch'], 'description': 'transdermal clonidine patch 5 mg q. 5 days', 'armGroupLabels': ['clonidine first - placebo second', 'placebo first - clonidine second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': "Ospedale Sant'Anna. Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna", 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Aldo Maina, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dipartimento di Ostetricia e Neonatologia. Servizio di Medicina Interna. Ospedale Sant'Anna Torino"}, {'name': 'Tullia Todros, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Head . Dipartimento di Ostetricia e Neonatologia. Università di Torino.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Unit of Obstetric Medicine. Principal Investigator', 'investigatorFullName': 'Aldo Maina', 'investigatorAffiliation': "Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna"}}}}