Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

NCT01110928 | Completed

• 3 other identifiers: GH-3812U1111-1114-6280JapicCTI-101123
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).

Conditions

Foetal Growth Problem; Small for Gestational Age

Outcome Measures

Primary Outcomes (1)

• Number and type of suspected serious adverse drug reactions (SADRs) during the study period

  evaluated binannually for 9 years

Secondary Outcomes (2)

• Number of glucose intolerance events during the study period

  evaluated biannually for 9 years

• Adult height

  Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician

Study Arms (1)

Norditropin®

Drug: somatropin

Interventions

somatropin DRUG

Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.

Norditropin®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.

You may qualify if:

• Participation in the GHLIQUID-1517 trial
• Patients with SGA (small for gestational age) short stature that are still growing

You may not qualify if:

• Known or suspected allergy to study product(s) or related products
• Diabetes Mellitus
• Patients with malignant tumor(s)
• Pregnant or likely to get pregnant

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (1)

• Toshiaki Tanaka et al, The effect of growth hormone treatment on age and height at puberty onset in short Japanese children born small for gestational age: interim analysis of Norditropin post-marketing study; Japan, Journal of Japanese Association for Human Auxology; 2017: Vol 23 No. 2 : p59

  BACKGROUND

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 27, 2010
• Study Start: November 26, 2009
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

JP (1)