This research study will be conducted to understand the side effects and effectiveness of the already marketed medicine named as SomatoRel™ (recombinant human growth hormone) in growth hormone deficient children (child is significantly shorter than children his or her age)
- Conditions
- Health Condition 1: E230- Hypopituitarism
- Registration Number
- CTRI/2020/07/026292
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd RLS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Pre-pubertal males less than 11 years of age and females less than 12 years of age.
2. Patients with diagnosis of growth failure due to idiopathic growth hormone deficiency confirmed during the screening by a standard GH stimulation test
3. Parents/guardian willing to give informed consent and patient willing to give assent (verbal or written) for the study as defined below:
- For children <7 years of age there is no need for written assent from the participant. However, verbal assent should be obtained in the presence of the parents/guardian.
- For children =7 and <12 years, verbal assent must be obtained in the presence of the parents/guardian and should be recorded by the parents/guardian.
1. Patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure.
2. Patients with active malignancy or intracranial tumor.
3. Patients with closed epiphyses.
4. Patients with Prader-Willi syndrome.
5. Patients with a known hypersensitivity to SomatoRelTM or any of its excipients.
6. Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
7. History of clinically significant diseases, e.g. progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study.
8. Patient participation in another clinical trial 30 days prior to SomatoRelTM administration.
9. Any other condition which investigator feels would pose a significant hazard to the patient, if SomatoRelTM is administered.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method