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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

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ClinicalTrials.gov Identifier: NCT03075644
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of this trial is 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.

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somapacitan Drug: Norditropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled 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
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018


Arm Intervention/treatment
Experimental: Somapacitan Drug: somapacitan
Once weekly subcutaneous injections (s.c., under the skin)

Active Comparator: Norditropin Drug: Norditropin
Daily subcutaneous injections (s.c., under the skin)




Primary Outcome Measures :
  1. Incidence of adverse events, including injection site reactions [ Time Frame: Week 0 - week 53 ]
    Count and % of events


Secondary Outcome Measures :
  1. Change in cross-sectional total adipose tissue compartments (TAT) [ Time Frame: Week 0, Week 52 ]
    The change is determined by quantitative computed tomography (CT) scans

  2. Change in subcutaneous adipose tissue compartments (SAT) [ Time Frame: Week 0, Week 52 ]
    The change is determined by quantitative computed tomography (CT) scans

  3. Change in intra-abdominal or visceral adipose tissue compartments (VAT) [ Time Frame: Week 0, Week 52 ]
    The change is determined by quantitative computed tomography (CT) scans

  4. Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) scores for effectiveness [ Time Frame: Week 0, Week 52 ]
    Treatment satisfaction questionnaire for medication-contains 9 items

  5. Change in TSQM-9 scores for convenience [ Time Frame: Week 0, Week 52 ]
    Treatment satisfaction questionnaire for medication-contains 9 items

  6. Change in TSQM-9 scores for global satisfaction [ Time Frame: Week 0, Week 52 ]
    Treatment satisfaction questionnaire for medication-contains 9 items



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075644


Locations
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Japan
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Novo Nordisk Investigational Site
Chiba-shi, Chiba, Japan, 260-8677
Novo Nordisk Investigational Site
Fukuoka, Japan, 818 8502
Novo Nordisk Investigational Site
Kagoshima, Japan, 890-8520
Novo Nordisk Investigational Site
Kobe, Hyogo, Japan, 650-0017
Novo Nordisk Investigational Site
Kyoto-shi Kyoto, Japan, 612-8555
Novo Nordisk Investigational Site
Okayama, Okayama, Japan, 700-8558
Novo Nordisk Investigational Site
Osaka, Japan, 565-0871
Novo Nordisk Investigational Site
Sagamihara-shi, Kanagawa, Japan, 252-0375
Novo Nordisk Investigational Site
Tokyo, Japan, 134-0088
Novo Nordisk Investigational Site
Yamagata-shi, Yamagata, Japan, 990-9585
Novo Nordisk Investigational Site
Yokohama, Kanagawa, Japan, 222-0036
Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03075644     History of Changes
Other Study ID Numbers: NN8640-4244
U1111-1181-1618 ( Other Identifier: World Health Organization (WHO) )
JapicCTI-173534 ( Registry Identifier: JAPIC )
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs