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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01109017
Other study ID # GH-3811
Secondary ID U1111-1114-6250J
Status Completed
Phase N/A
First received April 19, 2010
Last updated January 7, 2015
Start date October 2009
Est. completion date December 2014

Study information

Verified date January 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.


Recruitment information / eligibility

Status Completed
Enrollment 387
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Severe adult growth hormone deficiency

Exclusion Criteria:

- Known or suspected allergy to study product(s) or related products

- Previous participation in the study

- Diabetes Mellitus

- Presence of malignant tumor(s)

- Pregnant or likely to get pregnant

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
somatropin
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number and type of suspected serious adverse drug reactions (SADRs) during the study period after 5 years Yes
Secondary Number of impaired glucose tolerance events during the study period evaluated after 3 months, 6 months, 1 year and between 2-5 years Yes
Secondary Number of other types of adverse events (AEs) during the study period evaluated after 3 months, 6 months, 1 year and between 2-5 years Yes
Secondary Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density) evaluated after 3 months, 6 months, 1 year and between 2-5 years No
Secondary Effects of insulin-like growth factor-1 (IGF-I) levels evaluated after 3 months, 6 months, 1 year and between 2-5 years No
See also
  Status Clinical Trial Phase
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Completed NCT01562834 - Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Phase 4
Completed NCT01822340 - Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients Phase 2
Completed NCT01706783 - A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency Phase 1
Completed NCT00184730 - Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT00519558 - Growth Hormone Deficiency in Adults (GHDA) Phase 3
Terminated NCT01698944 - Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency Phase 4
Completed NCT03075644 - A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency Phase 3
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Terminated NCT01909479 - A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency Phase 3
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Recruiting NCT05979480 - The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life (GAMBOL Study)
Completed NCT02526420 - Versartis International Trial in Adults With Long-Acting Growth Hormone Phase 2
Completed NCT00934063 - An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® N/A
Completed NCT00715689 - Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 2
Completed NCT00297713 - Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Phase 2
Completed NCT01543880 - Safety and Efficacy of Long-term Somatropin Treatment in Adults N/A
Completed NCT01580605 - French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
Not yet recruiting NCT04867317 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) Phase 3