Skip to content

Trial · Interventional

TerminatedNot applicableResults postedRegistry data

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

NCTNCT00399893 (opens ClinicalTrials.gov in a new tab)Other idPro00005426Other idProtocol #00005426
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
5 participants (actual)
Sponsor
Duke University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Dec 2006
Primary completion
Apr 2009
Completion
Sept 2010
First posted
15 Nov 2006 (estimated)
Last update posted
24 Jul 2014 (estimated)
Conditions
Prader-Willi Syndrome

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. N/A

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

    NCT00399893

    Dec 2006 to Sept 2010

    Terminated

Registry summary

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

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).

Interventions

  • OctreotideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Octreotide

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

  • Placebo comparator

    Placebo

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

Primary outcomes9

Outcomes the sponsor listed as primary.

  1. Number of Participants With Decrease in Fasting Total Ghrelin

    Time frame · 6 months

    Registry description

    Number of participants showing a decrease in Fasting total ghrelin from baseline to 6 months of treatment with Octreotide or placebo

  2. Number of Participants With Decrease in Weight From Baseline to 6 Months

    Time frame · 6 months

    Registry description

    Number of participants who had a decrease in weight from baseline to 6 months of Octreotide or placebo therapy

  3. Number of Participants With Decreased BMI Z-score From Baseline to 6 Months

    Time frame · 6 months

    Registry description

    Number of participants with decreased BMI z-score from baseline to 6 months of Octreotide or Placebo therapy

  4. Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months

    Time frame · 6 months

    Registry description

    Number of participants with decreased skin-fold measurements from baseline to 6 months of Octreotide or Placebo therapy

  5. Number of Participants With Decrease in Hunger and Food Intake

    Time frame · 6 months

    Registry description

    Measured by hunger and hyperphagia by questionnaires and parent-reported 72-hour food recall from baseline to 6 months. Multiple questionnaires consisting of a battery of free text answer questions and food diaries are combined in order to make a behavioral assessment of the participants food state of hunger and food intake. There is no defined scale for this assessment. Each participants responses and parent responses are combined.

  6. Number of Participants With Improved Insulin Regulation From Baseline to 6 Months

    Time frame · 6 months

    Registry description

    Number of participants with improved Insulin regulation from baseline to 6 months of Octreotide or Placebo therapy. Insulin regulation was measured by immunochemiluminescent assay.

  7. Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months

    Time frame · 6 months

    Registry description

    Number of participants with improved Adiponectin regulation from baseline to 6 months of Octreotide or Placebo therapy

  8. Number of Participants With Improved Leptin Regulation From Baseline to 6 Months

    Time frame · 6 months

    Registry description

    Number of participants with improved Leptin regulation from baseline to 6 months of Octreotide or Placebo therapy

  9. Number of Participants With Improved Peptide YY (PYY) Regulation From Baseline to 6 Months

    Time frame · 6 months

    Registry description

    Number of participants with improved Peptide YY (PYY) regulation from baseline to 6 months of Octreotide or Placebo therapy

Secondary outcomes(2)

  1. Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD®

    Time frame · 6 months

    Registry description

    Number of participants with decreased body-composition as Measured by BOD POD® body composition tracking system from baseline to 6 months of Octreotide or Placebo therapy

  2. Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA

    Time frame · 6 months

    Registry description

    Number of participants with decreased body-composition as Measured by Dual Energy X-ray Absorptiometry (DEXA) scan from baseline to 6 months of Octreotide or Placebo therapy

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 outcomeNumber· 6 months

Number of Participants With Decrease in Fasting Total Ghrelin

GroupValue (Participants)
Octreotide1
Placebo Comparator1
Primary outcomeNumber· 6 months

Number of Participants With Decrease in Weight From Baseline to 6 Months

GroupValue (participants)
Octreotide0
Placebo Comparator2
Primary outcomeNumber· 6 months

Number of Participants With Decreased BMI Z-score From Baseline to 6 Months

GroupValue (participants)
Octreotide0
Placebo Comparator2
Primary outcome· 6 months

Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months

GroupValue
Octreotidenot posted
Placebo Comparatornot posted
Primary outcome· 6 months

Number of Participants With Decrease in Hunger and Food Intake

GroupValue
Octreotidenot posted
Placebo Comparatornot posted
Primary outcomeNumber· 6 months

Number of Participants With Improved Insulin Regulation From Baseline to 6 Months

GroupValue (participants)
Octreotide2
Placebo Comparator0
Secondary and other outcome results(2)
Secondary outcomeNumber· 6 months

Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD®

GroupValue (participants)
Octreotide2
Placebo Comparator3
Secondary outcomeNumber· 6 months

Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA

GroupValue (participants)
Octreotide0
Placebo Comparator0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OctreotideOctreotide : Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily–0 / 20 / 2
Placebo ComparatorPlacebo to be administered by subcutaneous injection three times daily while on study–0 / 31 / 3

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

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2003

Circulating ghrelin levels are suppressed by meals and octreotide therapy in children with Prader-Willi syndrome.

Haqq et al. 2003The Journal of clinical endocrinology and metabolismcited by 65

PMID 12915638DOI 10.1210/jc.2003-030205PUB-12915638

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 5 Years up to 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of PWS confirmed by chromosome analysis * Ages 5 years to 21 years * BMI for age ≥ (greater-than or equal to)85th percentile * Written informed consent and assent obtained and willingness to comply with the study schedule and procedures * Free T4, Thyroid stimulating hormone (TSH) values in the normal range (either endogenous or with thyroxine replacement) Exclusion Criteria: * Patients with any other clinically significant disease that would have an impact on body composition, including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders * Concomitant use of an investigational drug or Octreotide in the past year * Use of steroids for longer than 7 days within the past 30 days

PepBank is a research reference. Talk to a doctor before you use any peptide.