Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency

NCT00630487

Last updated date
Study Location
Pfizer Investigational Site
Bad Aibling, , 83043, Germany
Contact
1-800-718-1021

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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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males and females between 18 and 65 years of age

- Isolated growth hormone deficiency

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


- Isolated growth hormone deficiency by childhood onset


- Diabetes mellitus type 1 or 2

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
Official Title  ICMJE Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)
Brief Summary The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.
Detailed Description The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • Drug: Placebo
    Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.
  • Drug: Somatropin
    Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Verum
    Intervention: Drug: Somatropin
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 5, 2011)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2008)
50
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females between 18 and 65 years of age
  • Isolated growth hormone deficiency

Exclusion Criteria:

  • Isolated growth hormone deficiency by childhood onset
  • Diabetes mellitus type 1 or 2
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630487
Other Study ID Numbers  ICMJE A6281282
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 February 2013

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