Trial Outcomes & Findings for A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis (NCT NCT01625923)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

8 weeks

Results posted on

2019-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Olanzapine Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score \< 0.5 from baseline.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study on the Efficacy and Safety of Olanzapine in Gastroparesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olanzapine n=3 Participants Olanzapine
Age, Continuous	40.3 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Change in mean BMI

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.

Outcome measures

Outcome measures
Measure	Olanzapine n=3 Participants Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score \< 0.5 from baseline.
Change in Mean BMI Baseline BMI	23.5 kg/m^2 Standard Deviation 3.4
Change in Mean BMI BMI at Week 8	24.9 kg/m^2 Standard Deviation 3.6

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Olanzapine n=3 Participants Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score \< 0.5 from baseline.
Mean GCSI-DD Before/After Treatment With Olanzapine Baseline GCSI-DD Score	3.11 score on a scale Standard Error 0.42
Mean GCSI-DD Before/After Treatment With Olanzapine GCSI-DD Score After Intervention	2.17 score on a scale Standard Error 0.17

PRIMARY outcome

Timeframe: 8 weeks

Population: Change in mean serum glucose

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.

Outcome measures

Outcome measures
Measure	Olanzapine n=3 Participants Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score \< 0.5 from baseline.
Change in Mean Serum Glucose Baseline Serum Glucose	90.5 mg/dl Standard Deviation 0.7
Change in Mean Serum Glucose Serum Glucose at Week 8	90.5 mg/dl Standard Deviation 0.7

SECONDARY outcome

Timeframe: 8 weeks

Population: Change in mean gastric emptying time by WMC

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.

Outcome measures

Outcome measures
Measure	Olanzapine n=3 Participants Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score \< 0.5 from baseline.
Change in Mean Gastric Emptying Time Baseline GET (minutes)	468.3 minutes Standard Deviation 233.4
Change in Mean Gastric Emptying Time GET at Week 8 (minutes)	563.3 minutes Standard Deviation 582.6

SECONDARY outcome

Timeframe: 8 weeks

Population: Change in mean ghrelin levels over time

The investigators seek to determine whether olanzapine promotes secretion of ghrelin in gastroparesis.

Outcome measures

Outcome measures
Measure	Olanzapine n=3 Participants Subjects were enrolled to receive olanzapine open-label for 8 weeks. Subjects were initially started on olanzapine 2.5 mg by mouth daily at bedtime. Subjects returned on days 7 and 14 to determine response to medication. Medication dose was increased to 5 mg on day 7 and 10 mg on day 14, respectively, if there was incomplete symptom response, which was defined as a mean change in GCSI-DD score \< 0.5 from baseline.
Change in Mean Ghrelin Levels Over Time Baseline plasma ghrelin (pg/ml)	615.7 pg/ml Standard Deviation 339.1
Change in Mean Ghrelin Levels Over Time Plasma ghrelin at week 8 (pg/ml)	577.0 pg/ml Standard Deviation 253.4

Adverse Events

Olanzapine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Olanzapine n=3 participants at risk Olanzapine
General disorders Fatigue	66.7% 2/3 • 8 weeks
General disorders Weight gain	66.7% 2/3 • 8 weeks

Additional Information

Allen Lee

University of Michigan

Phone: 734-936-9454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place