Trial · NCT00399893
Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)
NCT00399893, Not applicable, Terminated, Duke University; results first posted 2014-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS). Trials, record NCT00399893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00399893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)
- NCT number
- NCT00399893
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 5 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Prader-Willi Syndrome
- Interventions
- Octreotide, Placebo
- First posted
- 2006-11-15
- Last updated
- 2014-07-24
- Results first posted
- 2014-07-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Decrease in Fasting Total Ghrelin | 6 months | Number of participants showing a decrease in Fasting total ghrelin from baseline to 6 months of treatment with Octreotide or placebo |
| Primary | Number of Participants With Decrease in Weight From Baseline to 6 Months | 6 months | Number of participants who had a decrease in weight from baseline to 6 months of Octreotide or placebo therapy |
| Primary | Number of Participants With Decreased BMI Z-score From Baseline to 6 Months | 6 months | Number of participants with decreased BMI z-score from baseline to 6 months of Octreotide or Placebo therapy |
| Primary | Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months | 6 months | Number of participants with decreased skin-fold measurements from baseline to 6 months of Octreotide or Placebo therapy |
| Primary | Number of Participants With Decrease in Hunger and Food Intake | 6 months | 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. |
| Primary | Number of Participants With Improved Insulin Regulation From Baseline to 6 Months | 6 months | Number of participants with improved Insulin regulation from baseline to 6 months of Octreotide or Placebo therapy. Insulin regulation was measured by immunochemiluminescent assay. |
| Primary | Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months | 6 months | Number of participants with improved Adiponectin regulation from baseline to 6 months of Octreotide or Placebo therapy |
| Primary | Number of Participants With Improved Leptin Regulation From Baseline to 6 Months | 6 months | Number of participants with improved Leptin regulation from baseline to 6 months of Octreotide or Placebo therapy |
| Primary | Number of Participants With Improved Peptide YY (PYY) Regulation From Baseline to 6 Months | 6 months | Number of participants with improved Peptide YY (PYY) regulation from baseline to 6 months of Octreotide or Placebo therapy |
| Secondary | Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD® | 6 months | 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Decrease in Fasting Total Ghrelin | 6 months | Descriptive statistics or percent of change from the baseline for the 5 patients was used.~A patient withdrew but included in analysis. | Participants | NUMBER |
| SECONDARY | Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD® | 6 months | Participant withdrew but data was used for analysis | participants | NUMBER |
| PRIMARY | Number of Participants With Decrease in Weight From Baseline to 6 Months | 6 months | participants | NUMBER | |
| PRIMARY | Number of Participants With Decreased BMI Z-score From Baseline to 6 Months | 6 months | A participant withdrew but was included in analysis | participants | NUMBER |
| PRIMARY | Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months | 6 months | The skin fold measurements were performed; however, the data was not completed in a manner that could be analyzed; therefore we could not analyze the data. Completed data is not available to complete this outcome. | ||
| PRIMARY | Number of Participants With Decrease in Hunger and Food Intake | 6 months | For this outcome measure, data from questionnaires and forms was not completed. Data for all questionnaires is not available to report. | ||
| SECONDARY | Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA | 6 months | Data for this outcome was not analyzed | participants | NUMBER |
| PRIMARY | Number of Participants With Improved Insulin Regulation From Baseline to 6 Months | 6 months | Participant withdrew but was used in the data analysis | participants | NUMBER |
| PRIMARY | Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months | 6 months | A participant withdrew but data was used for analysis | participants | NUMBER |
| PRIMARY | Number of Participants With Improved Leptin Regulation From Baseline to 6 Months | 6 months | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Decrease in Fasting Total Ghrelin | Octreotide | 1 | Participants | ||
| Number of Participants With Decrease in Fasting Total Ghrelin | Placebo Comparator | 1 | Participants | ||
| Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD® | Octreotide | 2 | participants | ||
| Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD® | Placebo Comparator | 3 | participants | ||
| Number of Participants With Decrease in Weight From Baseline to 6 Months | Octreotide | 0 | participants | ||
| Number of Participants With Decrease in Weight From Baseline to 6 Months | Placebo Comparator | 2 | participants | ||
| Number of Participants With Decreased BMI Z-score From Baseline to 6 Months | Octreotide | 0 | participants | ||
| Number of Participants With Decreased BMI Z-score From Baseline to 6 Months | Placebo Comparator | 2 | participants | ||
| Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA | Octreotide | 0 | participants | ||
| Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA | Placebo Comparator | 0 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octreotide | 2 | |
| Overall Study | STARTED | Placebo Comparator | 3 | |
| Overall Study | COMPLETED | Octreotide | 1 | |
| Overall Study | COMPLETED | Placebo Comparator | 3 | |
| Overall Study | NOT COMPLETED | Octreotide | 1 | |
| Overall Study | NOT COMPLETED | Placebo Comparator | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gallstones | Gastrointestinal disorders | Octreotide | 0 | 2 | 0 |
| other | Gallstones | Gastrointestinal disorders | Placebo Comparator | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octreotide | ||
| Total, all-cause mortality | Placebo Comparator | ||
| Total, other adverse events | Octreotide | 0 | 2 |
| Total, other adverse events | Placebo Comparator | 1 | 3 |
| Total, serious adverse events | Octreotide | 0 | 2 |
| Total, serious adverse events | Placebo Comparator | 0 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 12915638 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Octreotide vs Placebo Comparator: Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD® | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Improved Leptin Regulation From Baseline to 6 Months | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Improved Insulin Regulation From Baseline to 6 Months | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Decreased BMI Z-score From Baseline to 6 Months | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Decrease in Fasting Total Ghrelin | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Improved Peptide YY (PYY) Regulation From Baseline to 6 Months | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months | Trial comparisons |
| Octreotide vs Placebo Comparator: Number of Participants With Decrease in Weight From Baseline to 6 Months | Trial comparisons |
| Octreotide vs Placebo Comparator: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00399893
GET https://conductscience.org/api/trials/v1/NCT00399893/registered