A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00785772

First received: November 3, 2008

Last updated: October 31, 2011

Last verified: October 2011

History of Changes

Results First Received: March 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Renal Impairment
Intervention:	Drug: Gabapentin

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
Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A subject who had already been taking gabapentin was enrolled in the study.

Reporting Groups

	Description
Gabapentin	The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Description

Gabapentin

The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Participant Flow: Overall Study

	Gabapentin
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Gabapentin	The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Description

Gabapentin

The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.

Baseline Measures

	Gabapentin
Number of Participants [units: participants]	1
Age, Customized [units: Participant]
<=19 years	0
20-64 years	1
>=65 years	0
Gender [units: Participant]
Female	0
Male	1

Outcome Measures

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1. Primary:

Observed Plasma Gabapentin Concentration [ Time Frame: Days 8 and 15 ]

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2. Primary:

Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model [ Time Frame: Days 8 and 15 ]

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3. Primary:

Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration [ Time Frame: Days 8 and 15 ]

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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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study 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
The study was completed with an enrollment of 1 subject because prolongation of the study period or a change in the inclusion criteria (the upper limit of age was deleted) did not lead to further enrollment of subjects.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00785772 History of Changes
Other Study ID Numbers:	A9451169
Study First Received:	November 3, 2008
Results First Received:	March 29, 2011
Last Updated:	October 31, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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