Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

NCT00163189

Last updated date
Study Location
Hôpital Nord
Amiens, , 80030, France
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Glucocorticosteroid treatment for 12 months at least

- Bone age < 15 years for a boy and < 13 years for a girl

- Child measured height < - 2 SD, Child currently treated by GH

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Known diabetes (type 1 or type 2)


- A previous history of intolerance or hypersensitivity to the study drug or to drugs
with similar chemical structures

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Growth Hormone DeficiencyCross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects NCT01112865
  1. Brno - mesto,
  2. Olomouc,
  3. Praha 2,
  4. Praha 5,
  5. Datteln,
  6. Erlangen,
  7. Frankfurt-Niederrad,
  8. Gauting,
  9. Oldenburg,
  10. Den Haag,
  11. Rotterdam,
  12. Bratislava,
  13. Lubochna,
  14. Goteborg,
  15. Goteborg,
  16. Linkoping,
  17. Umea,
  18. Sihhiye, Ankara
  19. Capa, Istanbul
  20. Salford, Manchester
  21. Glasgow,
  22. London,
  23. Norwich,
ALL GENDERS
4 Years+
years
MULTIPLE SITES
Growth Hormone DeficiencyIGF1 Generation Test NCT00145457
  1. Besançon,
  2. Bordeaux,
  3. Dunkerque,
  4. Limoges Cedex,
  5. Nice,
  6. Paris Cedex 14,
  7. Tarbes,
  8. Toulouse Cedex 9,
ALL GENDERS
4 Years+
years
MULTIPLE SITES
Growth Hormone DeficiencyTransition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents NCT00156143
ALL GENDERS
15 Years+
years
MULTIPLE SITES
Growth Hormone DeficiencyPatient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD NCT03831880
  1. Aurora, Colorado
  2. Sacramento, California
  3. Aurora, Colorado
  4. Centennial, Colorado
  5. Greenwood Village, Colorado
  6. Jacksonville, Florida
  7. Jacksonville, Florida
  8. Orlando, Florida
  9. Orlando, Florida
  10. Pensacola, Florida
  11. Tampa, Florida
  12. Atlanta, Georgia
  13. Atlanta, Georgia
  14. Indianapolis, Indiana
  15. Indianapolis, Indiana
  16. Boston, Massachusetts
  17. Boston, Massachusetts
  18. Boston, Massachusetts
  19. Kansas City, Missouri
  20. Hackensack, New Jersey
  21. Pittsburgh, Pennsylvania
  22. Chattanooga, Tennessee
  23. Chattanooga, Tennessee
  24. Memphis, Tennessee
  25. Fort Worth, Texas
  26. Fort Worth, Texas
  27. Fort Worth, Texas
  28. Seattle, Washington
  29. Tacoma, Washington
  30. Tacoma, Washington
  31. Sofia,
  32. Varna,
  33. Brno,
  34. Brno,
  35. Praha 5,
  36. Praha 5,
  37. Bratislava,
  38. Bratislava,
  39. Kosice,
  40. Kosice,
  41. Glasgow,
  42. Glasgow,
  43. Glasgow,
  44. London,
  45. London,
  46. London,
  47. London,
  48. London,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
Official Title  ICMJE Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm
Brief Summary To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE Drug: Somatropin
Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
Study Arms  ICMJE Experimental: Somatropin
Intervention: Drug: Somatropin
Publications * Basmaison O, Ranchin B, Zouater H, Robertson A, Gomez R, Koppiker N. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy. Ann Endocrinol (Paris). 2019 Sep;80(4):202-210. doi: 10.1016/j.ando.2019.02.001. Epub 2019 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2015)
98
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Glucocorticosteroid treatment for 12 months at least
  • Bone age < 15 years for a boy and < 13 years for a girl
  • Child measured height < - 2 SD, Child currently treated by GH

Exclusion Criteria:

  • Known diabetes (type 1 or type 2)
  • A previous history of intolerance or hypersensitivity to the study drug or to drugs with similar chemical structures
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163189
Other Study ID Numbers  ICMJE A6281271
2004-002992-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP