Mesalamine 4 gm/60 mL Rectal Enema

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceuticals USA

ClinicalTrials.gov Identifier:

NCT00840203

First received: February 6, 2009

Last updated: September 1, 2009

Last verified: September 2009

History of Changes

Results First Received: June 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Rowasa® 4 gm/60 mL Rectal Enema Drug: Mesalamine 4 gm/60 mL Rectal Enema

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Mesalamine (Test) First	Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
Rowasa® (Reference) First	Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period

Participant Flow for 3 periods

Period 1: First Intervention

	Mesalamine (Test) First	Rowasa® (Reference) First
STARTED	37	35
COMPLETED	36	34
NOT COMPLETED	1	1
Protocol Violation	1	1

Period 2: Washout

	Mesalamine (Test) First	Rowasa® (Reference) First
STARTED	36	34
COMPLETED	35	34
NOT COMPLETED	1	0
Protocol Violation	1	0

Period 3: Second Intervention

	Mesalamine (Test) First	Rowasa® (Reference) First
STARTED	35	34
COMPLETED	35	34
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Mesalamine (Test) First	Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
Rowasa® (Reference) First	Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
Total	Total of all reporting groups

Baseline Measures

	Mesalamine (Test) First	Rowasa® (Reference) First	Total
Number of Participants [units: participants]	37	35	72
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	37	35	72
>=65 years	0	0	0
Gender [units: participants]
Female	14	12	26
Male	23	23	46
Race/Ethnicity, Customized [units: Participants]
Caucasian	18	17	35
Black	17	16	33
Hispanic	0	1	1
Biracial	0	1	1
Asian	2	0	2
Region of Enrollment [units: participants]
United States	37	35	72

Outcome Measures

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1. Primary:

Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 48 hour period ]

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2. Primary:

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 48 hour period ]

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3. Primary:

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 48 hour period ]

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4. Secondary:

Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 48 hour period ]

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5. Secondary:

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 48 hour period ]

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6. Secondary:

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 48 hour period ]

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Serious Adverse Events

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Other Adverse Events

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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: Principal Investigator is not permitted to discuss or publish trial results.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com

No publications provided

ClinicalTrials.gov Identifier:	NCT00840203 History of Changes
Other Study ID Numbers:	10336014
Study First Received:	February 6, 2009
Results First Received:	June 30, 2009
Last Updated:	September 1, 2009
Health Authority:	United States: Institutional Review Board

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