Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
NCT ID: NCT01927861
Last Updated: 2020-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
51 participants
INTERVENTIONAL
2013-08-19
2018-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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0.033 mg/kg/day
somatropin
Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.
0.066 mg/kg/day
somatropin
Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.
Interventions
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somatropin
Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.
Eligibility Criteria
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Inclusion Criteria
* Height SDS (standard deviation score): -2 SDS or below (according to the Japanese reference data)
* Age: boys 3 to below 11 years, girls 3 to below 10 years
* Height records must be available within the period between 40 and 64 weeks prior to Visit 1 (screening)
* Prepubertal children (definition for girls breast and pubes of Tanner stage is I, and none of menses, and for boys testicular volume below 4 mL, and pubes and penis of Tanner stage is I)
Exclusion Criteria
* Children with diabetic type diagnosed with the Japanese Diabetes Society Classification
* Children with history or presence of active malignancy
* Children who have received GH (growth hormone) treatment
* Children who have received systemic administration of the following medications within two years prior to Visit 1 (screening): Thyroid hormone (except replacement therapy), antithyroid hormone, androgen, oestrogen, progesterone, anabolic steroid, adrenocortical steroid treatment period for at least 13 weeks), derivative of gonadotropin releasing hormone and somatomedin C (IGF-I)
3 Years
10 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Asahikawa, Hokkaido, , Japan
Novo Nordisk Investigational Site
Fukuoka, , Japan
Novo Nordisk Investigational Site
Fukuoka, , Japan
Novo Nordisk Investigational Site
Iruma-gun, Saitama, , Japan
Novo Nordisk Investigational Site
Kanagawa, , Japan
Novo Nordisk Investigational Site
Kanagawa, , Japan
Novo Nordisk Investigational Site
Kyoto, , Japan
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, , Japan
Novo Nordisk Investigational Site
Miyazaki, , Japan
Novo Nordisk Investigational Site
Nagoya, Aichi, , Japan
Novo Nordisk Investigational Site
Niigata-shi, Niigata, , Japan
Novo Nordisk Investigational Site
Osaka, , Japan
Novo Nordisk Investigational Site
Osaka, , Japan
Novo Nordisk Investigational Site
Ōita, , Japan
Novo Nordisk Investigational Site
Saitama-city, Saitama, , Japan
Novo Nordisk Investigational Site
Saitama-shi, Saitama, , Japan
Novo Nordisk Investigational Site
Sapporo, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, , Japan
Novo Nordisk Investigational Site
Shizuoka, , Japan
Novo Nordisk Investigational Site
Tochigi, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Zentsuji, Kagawa, , Japan
Countries
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References
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Horikawa R, Ogata T, Matsubara Y, Yokoya S, Ogawa Y, Nishijima K, Endo T, Ozono K. Long-term efficacy and safety of two doses of Norditropin(R) (somatropin) in Noonan syndrome: a 4-year randomized, double-blind, multicenter trial in Japanese patients. Endocr J. 2020 Aug 28;67(8):803-818. doi: 10.1507/endocrj.EJ19-0371. Epub 2020 May 9.
Ozono K, Ogata T, Horikawa R, Matsubara Y, Ogawa Y, Nishijima K, Yokoya S. Efficacy and safety of two doses of Norditropin(R) (somatropin) in short stature due to Noonan syndrome: a 2-year randomized, double-blind, multicenter trial in Japanese patients. Endocr J. 2018 Feb 26;65(2):159-174. doi: 10.1507/endocrj.EJ17-0313. Epub 2017 Nov 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1131-5892
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-132336
Identifier Type: REGISTRY
Identifier Source: secondary_id
GHLIQUID-4020
Identifier Type: -
Identifier Source: org_study_id
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