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Trial record 1 of 1 for:    NCT02382939
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A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency (REAL 2)

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ClinicalTrials.gov Identifier: NCT02382939
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
Study Start Date : February 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


Arm Intervention/treatment
Experimental: somapacitan Drug: somapacitan
Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.

Active Comparator: hGH (somatropin) Drug: somatropin
Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Weeks 0 - 26 ]
  2. Incidence of injection site reactions [ Time Frame: Weeks 0- 26 ]

Secondary Outcome Measures :
  1. Occurrence of anti-NNC0195-0092 antibodies [ Time Frame: Baseline, week 26 ]
  2. Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scores (effectiveness,convenience, and global satisfaction scores) [ Time Frame: Baseline, week 26 ]


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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
  • Adult growth hormone deficiency diagnosed for 6 months or longer (defined as 180 days) prior to screening
  • Treatment with hGH (human growth hormone) for at least 6 months 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: Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. / Subjects with GHD (growth hormone deficiency) 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 file
  • For patients 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 MRI 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): NCT02382939


Locations
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Denmark
Novo Nordisk Investigational Site
København Ø, Denmark, 2100
Novo Nordisk Investigational Site
Odense, Denmark, 5000
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
France
Novo Nordisk Investigational Site
Angers, France, 49000
Novo Nordisk Investigational Site
Brest, France, 29609
Novo Nordisk Investigational Site
Bron, France, 69677
Novo Nordisk Investigational Site
DIJON cedex, France, 21079
Novo Nordisk Investigational Site
Saint Herblain, France, 44800
Germany
Novo Nordisk Investigational Site
Aachen, Germany, 52074
Novo Nordisk Investigational Site
Berlin, Germany, 10117
Novo Nordisk Investigational Site
Frankfurt, Germany, 60596
Japan
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, Japan, 173-8606
Novo Nordisk Investigational Site
Izumo, Shimane, Japan, 691-8501
Novo Nordisk Investigational Site
Kobe, Hyogo, Japan, 650-0017
Novo Nordisk Investigational Site
Kobe-shi, Hyogo, Japan, 657-0846
Novo Nordisk Investigational Site
Kyoto-shi Kyoto, Japan, 612-8555
Novo Nordisk Investigational Site
Okayama, Okayama, Japan, 700-8558
Novo Nordisk Investigational Site
Sagamihara-shi, Kanagawa, Japan, 252-0375
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 413 45
Novo Nordisk Investigational Site
Lund, Sweden, 221 85
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
United Kingdom
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B15 2TH
Novo Nordisk Investigational Site
Exeter, United Kingdom, EX2 5DW
Novo Nordisk Investigational Site
Leeds, United Kingdom, LS9 7TF
Novo Nordisk Investigational Site
London, United Kingdom, EC1A 7BE
Novo Nordisk Investigational Site
London, United Kingdom, SE5 9RS
Novo Nordisk Investigational Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02382939     History of Changes
Other Study ID Numbers: NN8640-4043
2014-000290-39 ( EudraCT Number )
U1111-1152-3664 ( Other Identifier: WHO )
JapicCTI-152850 ( Other Identifier: JAPIC )
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
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