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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Growth Hormone Use in Adults With Prader-Willi Syndrome

NCTNCT00444964 (opens ClinicalTrials.gov in a new tab)Other id303-C02R
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
11 participants (actual)
Sponsor
Children's Mercy Hospital Kansas City · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Apr 2005
Primary completion
1 Jan 2012
Completion
1 Jan 2012
First posted
8 Mar 2007 (estimated)
Last update posted
8 Jan 2021
Conditions
Prader-Willi Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 3

    Growth Hormone Use in Adults With Prader-Willi Syndrome

    NCT00444964

    Apr 2005 to 1 Jan 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months.

Interventions

  • Nutropin AQDrug

Arms1

  • Experimental

    Primary Cohort

    Nutropin AQ

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Body Composition

    Time frame · 12 and 24 months

    Registry description

    Anthropometric Measures and Body Composition

  2. Blood Chemistry

    Time frame · 12 and 24 months

    Registry description

    Insulin-like growth factor I- IGF-1

  3. Physical Activity

    Time frame · 12 and 24 months

    Registry description

    Duration of daily physical activity

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 and 24 months

Body Composition

GroupValue (percentage of body fat)Spread
Primary Cohort51.22.1
Primary outcomeMean· 12 and 24 months

Blood Chemistry

GroupValue (ng/ml)Spread
Primary Cohort9337.6
Primary outcomeMean· 12 and 24 months

Physical Activity

GroupValue (Minutes per Day)Spread
Primary Cohort17727

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Primary CohortNutropin AQ: 0.0125 mg/kg/day–1 / 110 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 16 to 60 years old * Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR) * Low IGF-1 level (e.g.,≤25%) at baseline * Ability to provide informed consent or availability of a suitable legally authorized representative Exclusion Criteria: * Pregnancy * Previous treatment with growth hormone * Uncontrolled endocrine disease, (i.e. diabetes or thyroid) * History of severe scoliosis * Heart disease * Uncontrolled high blood pressure or history of stroke * Morbid obesity (using PWS growth charts) * Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results

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