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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Evoke Pharma
ClinicalTrials.gov Identifier:
NCT00845858
First received: February 17, 2009
Last updated: June 17, 2014
Last verified: November 2013
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Gastroparesis
Diabetic Gastroparesis
Diabetes
Diabetes Mellitus
Delayed Gastric Emptying
Interventions: Drug: metoclopramide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Metoclopramide Nasal Spray 10 mg     Metoclopramide Nasal Spray 14 mg     Placebo Nasal Spray  
STARTED     96 [1]   96 [2]   95  
COMPLETED     88     84     87  
NOT COMPLETED     8     12     8  
Withdrawal by Subject                 5                 1                 1  
Adverse Event                 3                 8                 4  
Protocol Violation                 0                 0                 1  
not eligible                 0                 3                 2  
[1]

95 subjects received allocated intervention.

1 subject withdrew consent and was not dosed.

[2]

95 subjects received allocated intervention.

1 subject was not eligible and was not dosed.




  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Provides at least 80% power (alpha=0.05 two sided) to detect a mean difference between treatment groups of 0.5, for the GCSI-DD total score. Based on the literature, the standard deviation (SD) of the endpoint is approximately 1.1 resulting in a sample size of 77 per treatment group.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Metoclopramide Nasal Spray 10 mg     Metoclopramide Nasal Spray 14 mg     Placebo Nasal Spray     Total  
Number of Participants  
[units: participants]
  96     96     95     287  
Age  
[units: years]
Mean ± Standard Deviation
  51.6  ± 12.13     50.3  ± 12.40     52.4  ± 10.03     51.4  ± 11.56  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     81     83     85     249  
>=65 years     15     13     10     38  
Gender  
[units: participants]
       
Female     65     70     68     203  
Male     31     26     27     84  
Region of Enrollment  
[units: participants]
       
United States     96     96     95     287  



  Outcome Measures
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1.  Primary:   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.   [ Time Frame: 4 weeks ]

2.  Other Pre-specified:   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.   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marilyn R. Carlson
Organization: Evoke Pharma
phone: 858-345-1494
e-mail: mcarlson@evokepharma.com


No publications provided


Responsible Party: Evoke Pharma
ClinicalTrials.gov Identifier: NCT00845858     History of Changes
Other Study ID Numbers: METO-IN-002
Study First Received: February 17, 2009
Results First Received: April 17, 2014
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration