Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00738205
Status:
COMPLETED
Last Update Posted:
2014-03-11
First Post:
2008-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}, {'id': 'D014424', 'term': 'Turner Syndrome'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 834}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-10', 'studyFirstSubmitDate': '2008-08-19', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children.", 'timeFrame': 'week 12'}], 'secondaryOutcomes': [{'measure': 'To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.', 'timeFrame': 'week 12'}]}, 'conditionsModule': {'keywords': ['Electronic device', 'Growth hormone treatment'], 'conditions': ['Growth Hormone Deficiency', 'Turner Syndrome', 'Chronic Renal Failure', 'Small for Gestational Age']}, 'referencesModule': {'references': [{'pmid': '21294891', 'type': 'RESULT', 'citation': 'Bozzola M, Colle M, Halldin-Stenlid M, Larroque S, Zignani M; easypod survey study group. Treatment adherence with the easypod growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents. BMC Endocr Disord. 2011 Feb 4;11:4. doi: 10.1186/1472-6823-11-4.'}]}, 'descriptionModule': {'briefSummary': 'This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.\n\nBoth children naïve to growth hormone and dissatisfied with their current injection device will be recruited.', 'detailedDescription': 'An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone.\n\nThe study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overall, 834 children using the electronic auto-injector were recruited. Of these, 824 children were included in the evaluable population. Of the 824 evaluable children, 601 were treatment-naïve and 223 were treatment-experienced.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age \\[SGA\\] patients, based on RCP)\n\nExclusion Criteria:\n\n* Cases in which Saizen® is contra-indicated (based on local RCP)\n* Children returning for consultation, who have not brought back their Easypod™ electronic self-injector.\n* Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study"}, 'identificationModule': {'nctId': 'NCT00738205', 'briefTitle': 'Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders', 'orgStudyIdInfo': {'id': 'Easypod'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}, {'label': '2'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clément Olivier, MD, LMCC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Serono S.A., Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}