A Study of Zomacton in Children With Growth Hormone Deficiency

NCT ID: NCT00884000

Last Updated: 2012-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Genotropin

Intervention Type: DRUG

2

Group Type: EXPERIMENTAL

Zomacton

Intervention Type: DRUG

Interventions

Genotropin

Intervention Type: DRUG

Zomacton

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Semmelweiss University, 1st dept of paediatrics

Budapest, , Hungary

Szent Janos Kh Budai

Budapest, , Hungary

Petz Country Teaching Hospital

Győr, , Hungary

University of Szeged

Szeged, , Hungary

Markusovszkty Teaching Hospital

Szombathely, , Hungary

Associates in Clinical Endocrinology Education and Research (ACEER)

Chennai, , India

Apollo Hospitals

Hyderabad, , India

TOTALL Diabetes Hormone Institute

Indore, , India

KEM Hospital

Mumbai, , India

Prince Aly Khan Hospital

Mumbai, , India

Endocare Clinic

Nashik, , India

Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital

Pune, , India

Health & Research Centre

Trivandrum, , India

Haemek Medical Center

Afula, , Israel

Soroka University Medical Center

Beersheba, , Israel

Western Galilee Medical Center

Nahariya, , Israel

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Dana Children's Hospital - Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy

Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne, Gdańsk

Gdansk, , Poland

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, , Poland

SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin

Szczecin, , Poland

Societatea Civila Medicala "Dr. Paveliu"

Bucharest, , Romania

Spitalul Clinic Municipal "Filantropia"

Craiova, , Romania

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon"

Iași, , Romania

Spitalul Clinic Judetean Mures

Târgu Mureş, , Romania

Paediatric Endocrinology/Medicali's SRL

Timișoara, , Romania

Spitalul Clinic pentru Copii Louis Turcanu

Timișoara, , Romania

State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV

Kazan', , Russia

Federal State Institution

Moscow, , Russia

Russian Medical Academy of Post-graduate Education

Moscow, , Russia

Saint-Petersburg State Health Care Institution

Saint Petersburg, , Russia

State Educational Institution for Higher Professional Education

Saratov, , Russia

State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV

Tomsk, , Russia

Donetsk Regional Clinical Children's Hospital

Donetsk, , Ukraine

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

Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)

Odesa, , Ukraine

Zaporizhzhya Regional Paediatric Hospital

Zaporizhya, , Ukraine

Countries

Hungary; India; Israel; Poland; Romania; Russia; Ukraine

Other Identifiers

2008-004849-28

Identifier Type: -

Identifier Source: secondary_id

FE999905 CS07

Identifier Type: -

Identifier Source: org_study_id