Trial · NCT01923649
SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
NCT01923649, Phase 2, Completed, Universitaire Ziekenhuizen KU Leuven
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SOMATULINE Autogel 90 mg IN DUMPING SYNDROME. Trials, record NCT01923649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01923649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SOMATULINE Autogel 90 mg IN DUMPING SYNDROME
- NCT number
- NCT01923649
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Conditions
- Dumping Syndrome
- Interventions
- Lanreotide 90 mg slow release formulation, Placebo
- First posted
- 2013-08-15
- Last updated
- 2023-01-27
- Other registries' IDs
- eudract:2008-000643-34
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline Total Dumping score after treatment with Somatuline 90 mg and after placebo. | at week 11 and week 27 during the study | Early dumping starts immediately after a meal, within 1 hour (\< 1 hour). Late dumping starts later than 1 hour after a meal (≥ 1 hour). Each item is scored from zero (not present) 1 (mild) , 2 (moderate) and 3 (severe). Early dumping symptoms : sweating, flushes, dizziness, palpitations, abdominal pain, diarrhea, bloating, nausea. Late dumping symptoms : sweating, palpitations, hunger, drowsiness to unconsciousness, shaking and aggression. The change in dumping score will be assessed after 11 weeks and a second time after cross over at week 27. Additionally, the overall improvement is assessed by asking "how do you feel compared with your situation before starting the study at week 11. The same question is asked at week 27. Additionally at week 27 the following question is asked " How do you feel compared with your situation 4 months ago ?" Scoring is done on a 7 point Likert scale. |
| Secondary | Change in quality of life. | week 0, 11, 16 and 27 | To assess the effect of Somatuline 90 mg versus placebo on a standardized quality of life questionnaire (QOL SF-36). |
| Secondary | The difference in number of participants with adverse events between somatuline 90 mg versus placebo | at week 27 (end of the study) | To assess the tolerability of Somatuline 90 mg versus placebo. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01923649
GET https://conductscience.org/api/trials/v1/NCT01923649/registered