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MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children

NCT ID: NCT00452491

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-05-31

Study Completion Date

2010-04-30

Brief Summary

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1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
2. To specify the best period of treatment
3. To assess the efficacy of treatment based on final adult height of these children

Detailed Description

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Conditions

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Fetal Growth Retardation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years

2

Group Type ACTIVE_COMPARATOR

somatropin

Intervention Type DRUG

0.2 IU/kg/day 7 days per week given continuously for 3 years

Interventions

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somatropin

0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years

Intervention Type DRUG

somatropin

0.2 IU/kg/day 7 days per week given continuously for 3 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
* Height Less Than or Equal to -3 SD

Exclusion Criteria

* Age less than 3 years

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Marie SEBILLE, Dr

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Paris, , France

Site Status

Countries

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France

Other Identifiers

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FH5126A

Identifier Type: -

Identifier Source: org_study_id