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Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)

NCT00399893 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-07-24

Study results available
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Summary

The purpose of this study is to investigate over a 6 month period the effect of octreotide therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning calories, biomarkers of weight regulation and growth hormone markers in children and young Adults with Prader-Willi Syndrome(PWS).

Conditions

Interventions

DRUG

Octreotide

Octreotide to be administered by subcutaneous injection three times daily

DRUG

Placebo

Placebo to be administered by subcutaneous injection three times daily while on study

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Novartis

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Andrea M Haqq, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-04-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399893 on ClinicalTrials.gov