A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis
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|ClinicalTrials.gov Identifier: NCT01625923|
Recruitment Status : Terminated (Inadequate recruitment numbers)
First Posted : June 22, 2012
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Gastroparesis||Drug: Olanzapine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study on the Efficacy and Safety of Olanzapine in Improving Symptoms and Gastric Motility in Gastroparesis|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
An open-label pilot study of 20 consecutive subjects ages 18 - 70 with documented delayed gastric emptying within the past 2 years and history of nausea, vomiting, bloating, anorexia, early satiation, post-prandial fullness, and weight loss for at least 6 months without structural or organic cause will be enrolled.
Subjects will initially start on olanzapine 2.5 mg per mouth daily. Subjects will return on days 7 and 14 to determine response to medication and medication dose can be increased to 5 mg and 10 mg, respectively, based on incomplete symptom response (mean change GCSI-DD < 0.5). The total dose of olanzapine will not exceed 10 mg daily during this study and subjects will continue on treatment for a total of 8 weeks.
Other Name: Zyprexa
- Change in Mean BMI [ Time Frame: 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.
- Mean GCSI-DD Before/After Treatment With Olanzapine [ Time Frame: 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).
- Change in Mean Serum Glucose [ Time Frame: 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.
- Change in Mean Gastric Emptying Time [ Time Frame: 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.
- Change in Mean Ghrelin Levels Over Time [ Time Frame: 8 weeks ]The investigators seek to determine whether olanzapine promotes secretion of ghrelin in gastroparesis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625923
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Allen Lee, MD||University of Michigan|
|Principal Investigator:||Braden Kuo, MD||Massachusetts General Hospital|
|Principal Investigator:||William Hasler, MD||University of Michigan|