Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT01442688

First received: September 26, 2011

Last updated: August 16, 2012

Last verified: August 2012

History of Changes

Results First Received: August 16, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Healthy
Interventions:	Drug: Amoxicillin + MMX placebo Drug: Amoxicillin + MMX mesalazine/mesalamine

Participant Flow

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Recruitment Details

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Pre-Assignment Details

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Reporting Groups

	Description
Amoxicillin + MMX Placebo First	MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
Amoxicillin + MMX Mesalazine/Mesalamine First	MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.

Participant Flow for 2 periods

Period 1: First Intervention

	Amoxicillin + MMX Placebo First	Amoxicillin + MMX Mesalazine/Mesalamine First
STARTED	31	31
COMPLETED	29	31
NOT COMPLETED	2	0
Withdrawal by Subject	1	0
subject incarcerated	1	0

Period 2: Second Intervention

	Amoxicillin + MMX Placebo First	Amoxicillin + MMX Mesalazine/Mesalamine First
STARTED	29	31
COMPLETED	28	31
NOT COMPLETED	1	0
Adverse Event	1	0

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.
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Reporting Groups

	Description
Amoxicillin + MMX Placebo First	MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
Amoxicillin + MMX Mesalazine/Mesalamine First	MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
Total	Total of all reporting groups

Baseline Measures

	Amoxicillin + MMX Placebo First	Amoxicillin + MMX Mesalazine/Mesalamine First	Total
Overall Participants Analyzed [Units: Participants]	31	31	62

Age [Units: Years] Mean (Standard Deviation)	34.3 (11.2)	30.1 (8.91)	32.2 (10.3)

Age, Customized [Units: Participants]
Between 18 and 55 years	31	31	62

Gender [Units: Participants]
Female	7	9	16
Male	24	22	46

Region of Enrollment [Units: Participants]
United States	31	31	62

Outcome Measures

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1. Primary:

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ]

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2. Primary:

Maximum Plasma Concentration (Cmax) for Amoxicillin [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

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):

Pierce D, Corcoran M, Martin P, Barrett K, Inglis S, Preston P, Thompson TN, Willsie SK. Effect of MMX® mesalamine coadministration on the pharmacokinetics of amoxicillin, ciprofloxacin XR, metronidazole, and sulfamethoxazole: results from four randomized clinical trials. Drug Des Devel Ther. 2014 May 14;8:529-43. doi: 10.2147/DDDT.S55373. eCollection 2014.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01442688 History of Changes
Other Study ID Numbers:	SPD476-114
Study First Received:	September 26, 2011
Results First Received:	August 16, 2012
Last Updated:	August 16, 2012

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