Skip to main content
OpenTrials
Completed

NCT Number: NCT02693522

Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency

The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyunghee University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 and up
  • Patients with maximum serum growth hormone concentration of less than 5 ng/ml
  • Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study
  • Persons who have agreed in writing to participate in this study

Exclusion criteria

  • Persons who are currently under treatment after being diagnosed with a malignant tumor
  • Hepatosis
  • Renal function disorder
  • Intra-cranial hypertension
  • Proliferative diabetic retinopathy
  • Persons who carry acromegaly activity
  • Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin)
  • Mental patients and/or drug addicts and alcoholics
  • Patients who had participated in the other drug study within the last 30 days prior to participating in this study
  • Patients considered unfit for this study by the attending physician

Treatment and study plan

Somatropin

Drug

Subcutaneous injection

Eutropin

Drug

Subcutaneous injection

Primary outcomes

  1. Degree of fat mass (FM) reduction

    Time frame: baseline and 24 weeks

    statistically difference for change from baseline (kg)

Secondary outcomes

  1. Degree of variation in Lean Body Mass

    Time frame: baseline and 24 weeks

    statistically difference for change from baseline (kg)

  2. Degree of variation in Waist to Hip Ratio

    Time frame: baseline and 24 weeks

    statistically difference for change from baseline

  3. Degree of variation in IGF-1

    Time frame: baseline and 24 weeks

    statistically difference for change from baseline (ng/ml)

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Feb 26, 2016
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.