A Study of Zomacton in Children With Growth Hormone Deficiency

Phase 3

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Genotropin; Drug: Zomacton

• Registration Number: NCT00884000
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2010-01
• Primary Completion: 2012-06
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

1. Signed informed consent
2. Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
3. Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of <10ng/ml pr lower if so required by the country specific board(s)
4. Height SDS <-2 SD of ref value for CA
5. Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
6. Height recorded for at least 6 months but not more than 18 months of pre-screening
7. The difference between CA-BA≥ 1
8. A positive locally performed GH stimulation test (defined as a peak plasma level of<9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening

Exclusion Criteria

1. BA above 9 yrs for girls and 10 yrs for boys
2. Puberty Tanner stage >1
3. Weight <12 Kg at screening
4. Any prior treatment with GH
5. Closed epiphysis
6. Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
7. Any other diagnosed or suspected endocrine or metabolic disorder
8. Any diagnosed or suspected sever chronic disease
9. Clinical signs of dysmorphic features, malformations or mental retardations
10. Growth failure due to other disorders
11. Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
12. Diagnosed malignant disease
13. Any abnormal CS lab results that requires further investigation
14. Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial
15. Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Genotropin	-
2	Zomacton	-

Primary Outcome Measures

Name	Time	Method
Height Velocity	12 months

Secondary Outcome Measures

Name	Time	Method
BA (Bone Age)	12 months
Change in IGF-1 and IGFBP-3	12 months
Anti-hGH AB	12 months
CS Changes in safety lab, physical examination and vital signs	12 months
Height SDS	12 months
Height velocity SDS	12 months
AE and tolerability	12 months

Trial Locations

Locations (43)

University of Szeged; 🇭🇺 Szeged, Hungary

Petz Country Teaching Hospital; 🇭🇺 Gyor, Hungary

TOTALL Diabetes Hormone Institute; 🇮🇳 Indore, India

Spitalul Clinic pentru Copii Louis Turcanu; 🇷🇴 Timisoara, Romania

State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV; 🇷🇺 Kazan, Russian Federation

Endocare Clinic; 🇮🇳 Nasik, India

Health & Research Centre; 🇮🇳 Trivandrum, India

SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin; 🇵🇱 Szczecin, Poland

Societatea Civila Medicala "Dr. Paveliu"; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Municipal "Filantropia"; 🇷🇴 Craiova, Romania

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon"; 🇷🇴 Iasi, Romania

Spitalul Clinic Judetean Mures; 🇷🇴 Targu Mures, Romania

Markusovszkty Teaching Hospital; 🇭🇺 Szombathely, Hungary

Associates in Clinical Endocrinology Education and Research (ACEER); 🇮🇳 Chennai, India

Western Galilee Medical Center; 🇮🇱 Nahariya, Israel

Saint-Petersburg State Health Care Institution; 🇷🇺 Saint Petersburg, Russian Federation

Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital); 🇺🇦 Odessa, Ukraine

Zaporizhzhya Regional Paediatric Hospital; 🇺🇦 Zaporizhya, Ukraine

Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital; 🇮🇳 Pune, India

Apollo Hospitals; 🇮🇳 Hyderabad, India

KEM Hospital; 🇮🇳 Mumbai, India

Prince Aly Khan Hospital; 🇮🇳 Mumbai, India

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel

Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Dana Children's Hospital - Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

State Educational Institution for Higher Professional Education; 🇷🇺 Saratov, Russian Federation

Semmelweiss University, 1st dept of paediatrics; 🇭🇺 Budapest, Hungary

Haemek Medical Center; 🇮🇱 Afula, Israel

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne, Gdańsk; 🇵🇱 Gdansk, Poland

Uniwersytecki Szpital Dziecięcy w Krakowie; 🇵🇱 Krakow, Poland

Federal State Institution; 🇷🇺 Moscow, Russian Federation

Paediatric Endocrinology/Medicali's SRL; 🇷🇴 Timisoara, Romania

State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV; 🇷🇺 Tomsk, Russian Federation

Donetsk Regional Clinical Children's Hospital; 🇺🇦 Donetsk, Ukraine

Russian Medical Academy of Post-graduate Education; 🇷🇺 Moscow, Russian Federation

Ivano-Frankivsk Regional Children Clinical Hospital; 🇺🇦 Ivano-Frankivsk, Ukraine

Kharkiv Regional Clinical Children's Hospital; 🇺🇦 Kharkiv, Ukraine

Institute of Endocrinology and Metabolism; 🇺🇦 Kiev, Ukraine

Ukrainian Children's Specialized Clinical Hospital; 🇺🇦 Kiev, Ukraine

Szent Janos Kh Budai; 🇭🇺 Budapest, Hungary