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Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01418365
First received: August 15, 2011
Last updated: August 21, 2013
Last verified: August 2013
History of Changes
Results First Received: July 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: Metronidazole + MMX Mesalazine/mesalamine placebo
Drug: Metronidazole + MMX Mesalazine/mesalamine

  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
Metronidazole + MMX Placebo First Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
Metronidazole + MMX Mesalazine/Mesalamine First Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second

Participant Flow for 2 periods

 Period 1:   First Intervention
    Metronidazole + MMX Placebo First   Metronidazole + MMX Mesalazine/Mesalamine First
STARTED   15   15 
COMPLETED   14   14 
NOT COMPLETED   1   1 
Withdrawal by Subject                0                1 
Non-compliance                1                0 

Period 2:   Second Intervention
    Metronidazole + MMX Placebo First   Metronidazole + MMX Mesalazine/Mesalamine First
STARTED   14   14 
COMPLETED   14   13 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 



  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.
No text entered.

Reporting Groups
  Description
Metronidazole + MMX Placebo First Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
Metronidazole + MMX Mesalazine/Mesalamine First Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
Total Total of all reporting groups

Baseline Measures
   Metronidazole + MMX Placebo First   Metronidazole + MMX Mesalazine/Mesalamine First   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 15   15   30 
Age 
[Units: Years]
Mean (Standard Deviation) 		 35.9  (8.84)   31.2  (11.0)   33.6  (10.1) 
Age, Customized 
[Units: Participants]
 		     
Between 18 and 55 years   15   15   30 
Gender 
[Units: Participants]
 		     
Female   6   6   12 
Male   9   9   18 
Region of Enrollment 
[Units: Participants]
 		     
United States   15   15   30 


  Outcome Measures
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1.  Primary:   Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole   [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ]
  Show Outcome Measure 1

2.  Primary:   Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole   [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Pharmaceutical
phone: 1 866-842-5335


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01418365     History of Changes
Other Study ID Numbers: SPD476-116
Study First Received: August 15, 2011
Results First Received: July 16, 2012
Last Updated: August 21, 2013