Trial · NCT01625923
A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis
NCT01625923, Not applicable, Terminated, University of Michigan; results first posted 2019-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis. Trials, record NCT01625923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01625923
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis
- NCT number
- NCT01625923
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Idiopathic Gastroparesis
- Interventions
- Olanzapine
- First posted
- 2012-06-22
- Last updated
- 2019-09-10
- Results first posted
- 2019-09-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean BMI | 8 weeks | Subjects will undergo regular testing of blood glucose, insulin, hemoglobin (Hgb) A1c, body mass index (BMI), liver enzymes, thyroid stimulating hormone (TSH), and prolactin levels during the study as well as after treatment completion to determine the safety of the medication. All adverse events will be compiled to investigate the tolerability of the medication. |
| Primary | Mean GCSI-DD Before/After Treatment With Olanzapine | 8 weeks | The investigators will utilize the gastroparesis cardinal symptom index daily diary (GCSI-DD) to compare severity of symptoms before and after treatment with olanzapine. The total GCSI-DD is a validated questionnaire that measures the daily relevant symptoms of gastroparesis and ranges from 0 (no symptoms) to 5 (severe symptoms). |
| Primary | Change in Mean Serum Glucose | 8 weeks | Subjects will undergo regular testing of blood glucose, insulin, hemoglobin (Hgb) A1c, body mass index (BMI), liver enzymes, thyroid stimulating hormone (TSH), and prolactin levels during the study as well as after treatment completion to determine the safety of the medication. All adverse events will be compiled to investigate the tolerability of the medication. |
| Secondary | Change in Mean Gastric Emptying Time | 8 weeks | The investigators aim to test gastric motility, including gastric emptying and antroduodenal contractility parameters, by wireless motility capsule (WMC) before and at the completion of the study to determine if olanzapine has any pro-motility effects in gastroparesis. |
| Secondary | Change in Mean Ghrelin Levels Over Time | 8 weeks | The investigators seek to determine whether olanzapine promotes secretion of ghrelin in gastroparesis. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean BMI | 8 weeks | Change in mean BMI | kg/m^2 | MEAN |
| PRIMARY | Mean GCSI-DD Before/After Treatment With Olanzapine | 8 weeks | score on a scale | MEAN | |
| PRIMARY | Change in Mean Serum Glucose | 8 weeks | Change in mean serum glucose | mg/dl | MEAN |
| SECONDARY | Change in Mean Gastric Emptying Time | 8 weeks | Change in mean gastric emptying time by WMC | minutes | MEAN |
| SECONDARY | Change in Mean Ghrelin Levels Over Time | 8 weeks | Change in mean ghrelin levels over time | pg/ml | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean BMI | Olanzapine | Baseline BMI | 23.5 | Standard Deviation 3.4 | kg/m^2 |
| Change in Mean BMI | Olanzapine | BMI at Week 8 | 24.9 | Standard Deviation 3.6 | kg/m^2 |
| Mean GCSI-DD Before/After Treatment With Olanzapine | Olanzapine | Baseline GCSI-DD Score | 3.11 | Standard Error 0.42 | score on a scale |
| Mean GCSI-DD Before/After Treatment With Olanzapine | Olanzapine | GCSI-DD Score After Intervention | 2.17 | Standard Error 0.17 | score on a scale |
| Change in Mean Serum Glucose | Olanzapine | Baseline Serum Glucose | 90.5 | Standard Deviation 0.7 | mg/dl |
| Change in Mean Serum Glucose | Olanzapine | Serum Glucose at Week 8 | 90.5 | Standard Deviation 0.7 | mg/dl |
| Change in Mean Gastric Emptying Time | Olanzapine | Baseline GET (minutes) | 468.3 | Standard Deviation 233.4 | minutes |
| Change in Mean Gastric Emptying Time | Olanzapine | GET at Week 8 (minutes) | 563.3 | Standard Deviation 582.6 | minutes |
| Change in Mean Ghrelin Levels Over Time | Olanzapine | Baseline plasma ghrelin (pg/ml) | 615.7 | Standard Deviation 339.1 | pg/ml |
| Change in Mean Ghrelin Levels Over Time | Olanzapine | Plasma ghrelin at week 8 (pg/ml) | 577.0 | Standard Deviation 253.4 | pg/ml |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olanzapine | 3 | |
| Overall Study | COMPLETED | Olanzapine | 3 | |
| Overall Study | NOT COMPLETED | Olanzapine | 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 | Fatigue | General disorders | Olanzapine | 2 | 3 | |
| other | Weight gain | General disorders | Olanzapine | 2 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olanzapine | 0 | 3 |
| Total, other adverse events | Olanzapine | 2 | 3 |
| Total, serious adverse events | Olanzapine | 0 | 3 |
Source ClinicalTrials.gov
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/NCT01625923
GET https://conductscience.org/api/trials/v1/NCT01625923/registered