Trial Outcomes & Findings for Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis (NCT NCT00845858)

Last Updated: 2014-06-27

Results Overview

Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo. The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe). 1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up) 2. Early satiety (not able to finish a normal sized meal) 3. Bloating (feeling like you need to loosen clothes) 4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period. A mean change (improvement) of \>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

287 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Metoclopramide Nasal Spray 10 mg metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Metoclopramide Nasal Spray 14 mg metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Placebo Nasal Spray Placebo: 30 minutes before meals and at bedtime
Overall Study STARTED	96	96	95
Overall Study COMPLETED	88	84	87
Overall Study NOT COMPLETED	8	12	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Metoclopramide Nasal Spray 10 mg metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Metoclopramide Nasal Spray 14 mg metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Placebo Nasal Spray Placebo: 30 minutes before meals and at bedtime
Overall Study Withdrawal by Subject	5	1	1
Overall Study Adverse Event	3	8	4
Overall Study Protocol Violation	0	0	1
Overall Study not eligible	0	3	2

Baseline Characteristics

Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metoclopramide Nasal Spray 10 mg n=96 Participants metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Metoclopramide Nasal Spray 14 mg n=96 Participants metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Placebo Nasal Spray n=95 Participants Placebo: 30 minutes before meals and at bedtime	Total n=287 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 12.13 • n=5 Participants	50.3 years STANDARD_DEVIATION 12.40 • n=7 Participants	52.4 years STANDARD_DEVIATION 10.03 • n=5 Participants	51.4 years STANDARD_DEVIATION 11.56 • n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	83 Participants n=7 Participants	85 Participants n=5 Participants	249 Participants n=4 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	70 Participants n=7 Participants	68 Participants n=5 Participants	203 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	84 Participants n=4 Participants
Region of Enrollment United States	96 participants n=5 Participants	96 participants n=7 Participants	95 participants n=5 Participants	287 participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Metoclopramide Nasal Spray 10 mg n=96 Participants metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Metoclopramide Nasal Spray 14 mg n=96 Participants metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Placebo Nasal Spray n=95 Participants Placebo: 30 minutes before meals and at bedtime
The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.	-1.2 units on a scale Standard Deviation 1.18	-1.2 units on a scale Standard Deviation 0.94	-1.0 units on a scale Standard Deviation 0.89

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo. The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe). 1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up) 2. Early satiety (not able to finish a normal sized meal) 3. Bloating (feeling like you need to loosen clothes) 4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period. A mean change (improvement) of \>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.

Outcome measures

Outcome measures
Measure	Metoclopramide Nasal Spray 10 mg n=65 Participants metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Metoclopramide Nasal Spray 14 mg n=70 Participants metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Placebo Nasal Spray n=68 Participants Placebo: 30 minutes before meals and at bedtime
The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender.	-1.2 units on a scale Standard Deviation 1.18	-1.3 units on a scale Standard Deviation 0.98	-0.8 units on a scale Standard Deviation 0.79

Adverse Events

Metoclopramide Nasal Spray 10 mg

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Metoclopramide Nasal Spray 14 mg

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Placebo Nasal Spray

Serious events: 3 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Metoclopramide Nasal Spray 10 mg n=95 participants at risk metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Metoclopramide Nasal Spray 14 mg n=95 participants at risk metoclopramide: 30 minutes before meals and at bedtime for 4 weeks	Placebo Nasal Spray n=95 participants at risk Placebo: 30 minutes before meals and at bedtime
General disorders Non cardiac chest pain	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	1.1% 1/95 • Number of events 1 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.
Hepatobiliary disorders Cholelithiasis	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	1.1% 1/95 • Number of events 1 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.
Infections and infestations Kidney infection	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	1.1% 1/95 • Number of events 1 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	1.1% 1/95 • Number of events 1 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	1.1% 1/95 • Number of events 1 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.
General disorders Condition aggravated	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	1.1% 1/95 • Number of events 1 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.	0.00% 0/95 • All adverse events (AEs) (from signing of Informed Consent Form until termination of study drug [28 days]), whether observed by the Investigator, reported by the subject, from laboratory findings, or other means, were captured. All AEs were followed in accordance with good medical practice until resolved or fully characterized. AEs that were ongoing at the end of the study were followed for at least 72 hours to determine the status of the event. All serious and related AEs that occurred within 30 days after the last dose of study drug were captured.

Other adverse events

Additional Information

Marilyn R. Carlson

Evoke Pharma

Phone: 858-345-1494

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60