Growth Retardation In Children With Special Pathological Conditions Or Disease

NCT00163215 | Completed Phase 3 Results DMC

• 1 other identifier: A6281269
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 18

Brief Summary

To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Conditions

Endocrine System Diseases

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population

  Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population.

  Baseline, Month 36

• Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population

  Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx-height Y\[x-1\])/(\[date of Yx-date of Y{x-1}\]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. SDS indicates how similar participant was to reference population.

  Baseline, Month 36

Secondary Outcomes (15)

• Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population

  Baseline, Month 12, Month 24, Month 36

• Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population

  Baseline, Month 12, Month 24, Month 36

• Height

  Baseline, Month 12, Month 24, Month 36

• Change From Baseline in Height at Month 12, Month 24 and Month 36

  Baseline, Month 12, Month 24, Month 36

• Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)

  Baseline, Month 12, Month 24, Month 36

Study Arms (1)

Somatropin

EXPERIMENTAL

Drug: Somatropin

Interventions

Somatropin DRUG

Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years

Somatropin

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Bone age \< 13 years for a boy and \< 11 years for a girl
• Naive child: Measured Height \< -2.5 SD for CA
• Child currently treated by GH

You may not qualify if:

• Idiopathic short stature
• Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Pfizer Investigational Site

Annemasse, 74107, France

Location

Pfizer Investigational Site

Besançon, 25030, France

Location

Pfizer Investigational Site

Bordeaux, 33000, France

Location

Pfizer Investigational Site

Bordeaux, 33076, France

Location

Pfizer Investigational Site

Bron, 69677, France

Location

Pfizer Investigational Site

Dijon, 21000, France

Location

Pfizer Investigational Site

Grenoble, 38043, France

Location

Pfizer Investigational Site

Lorient, 56100, France

Location

Pfizer Investigational Site

Lyon, 69322, France

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Montpellier, 34059, France

Location

Pfizer Investigational Site

Paris, 75015, France

Location

Pfizer Investigational Site

Paris, 75019, France

Location

Pfizer Investigational Site

Paris, 75571, France

Location

Pfizer Investigational Site

Paris, 75674 Cedex, France

Location

Pfizer Investigational Site

Pringy, 74374, France

Location

Pfizer Investigational Site

Toulouse, 31026, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: January 1, 2005
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 19, 2012
• Results First Posted: December 19, 2012

Record last verified: 2012-11

Locations

FR (18)