Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-30 @ 12:12 AM
Study NCT ID:
NCT01306357
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2011-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014424', 'term': 'Turner Syndrome'}], 'ancestors': [{'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': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2011-02-28', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall treatment compliance', 'timeFrame': 'up to three years'}], 'secondaryOutcomes': [{'measure': 'Description of the auxological and biochemical characteristics of the population at inclusion (notably the exploration of GH deficiency, the height, the difference in height from the average in SD, the rate of growth prior to treatment)', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Description of the Dosages of Growth Hormone and way of use of needle-free device', 'timeFrame': 'up to 3 years'}, {'measure': 'Description of the evolution of the auxological and biochemical parameters (gain in height in SD, growth rate, IGF-1 if available)', 'timeFrame': 'Baseline (Day 0), up to three years'}, {'measure': 'Average Duration of Treatment', 'timeFrame': 'up to three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Turner's syndrome", 'somatropin', 'human growth hormone deficiency'], 'conditions': ["Turner's Syndrome", 'Human Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': "The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients.\n\nSomatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution.\n\nThe use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training.\n\nIn April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device.\n\nThe number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum.\n\nThe rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients who meet the criteria of the Treatment Information Sheet (growth hormone deficiency or Turner's syndrome) for which treatment is initiated with Zomacton® 4 mg using the Zomajet® 2 Vision needle-free device or with Zomacton® 10 mg using the Zomajet® Vision X.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Growth hormone deficiency\n* Turner's syndrome\n\nExclusion Criteria:\n\n* Patients who do not meet the criteria in the treatment Information Sheet"}, 'identificationModule': {'nctId': 'NCT01306357', 'acronym': 'ZOMAJET', 'briefTitle': 'Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': "Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective", 'orgStudyIdInfo': {'id': 'RZO 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Zomacton® with Zomajet® needle-free device', 'description': 'Zomacton® 4 mg delivered by percutaneous transjection (needle-free) using the Zomajet® 2 Vision device or Zomacton® 10 mg delivered by percutaneous transjection (needle-free) using the Zomajet® Vision X needle-free device.', 'interventionNames': ['Drug: Somatropin']}], 'interventions': [{'name': 'Somatropin', 'type': 'DRUG', 'otherNames': ['human growth hormone', 'Zomacton'], 'description': '4 mg or 10 mg delivered by needle-free device', 'armGroupLabels': ['Zomacton® with Zomajet® needle-free device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Antibes Juan Les Pins', 'country': 'France', 'facility': 'Investigational site'}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brive-la-Gaillarde', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'city': 'Hyères', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lille', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lisieux', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 49.1466, 'lon': 0.22925}}, {'city': 'Montivilliers', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 49.54518, 'lon': 0.18769}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nieul-sur-Mer', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 46.20378, 'lon': -1.1678}}, {'city': 'Paris', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Puyricard', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.58269, 'lon': 5.42064}}, {'city': 'Tarbes', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'city': 'Toulon', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Investigational site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}