Safety and Efficacy of Gabapentin in Postherpetic Neuralgia

This study has been completed.

Study NCT00636636 Information provided by Depomed

First Received on February 21, 2008. Last Updated on January 27, 2012 History of Changes

Results First Received: October 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Neuralgia,Postherpetic
Interventions:	Drug: Gabapentin Extended Release tablets 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
Recruitment period was from March 2008 through May 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study included screening visit, wash-out from all PHN medications as necessary, followed by a week of baseline period. Patients who successfully completed the baseline week, if still continues to meet entry criteria, then get randomized to Active or Placebo groups.

Reporting Groups

	Description
G-ER	Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
Placebo	Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing

Participant Flow: Overall Study

	G-ER	Placebo
STARTED	221	231
Safety & Efficacy of Gabapentin ER	186	194 ^[1]
379	186	194 ^[1]
COMPLETED	185	192
NOT COMPLETED	36	39
Other reason	4	6
Adverse Event	19	8
Lack of Efficacy	7	12
Protocol Violation	2	2
Lost to Follow-up	0	1
Death	0	1
Withdrawal by Subject	4	9

[1]	1 patient randomized twice, not included in ITT, but completed medication and counted as completer

Baseline Characteristics

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Reporting Groups

	Description
G-ER	Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
Placebo	Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing

Baseline Measures

	G-ER	Placebo	Total
Number of Participants [units: participants]	220	230	450
Age [units: years] Mean ± Standard Deviation	65.3 ± 13.3	65.9 ± 11.1	65.6 ± 12.2
Age, Customized ^[1] [units: participants]
<65 years	81	89	170
65 to 74 years	82	86	168
>=75 years	57	55	112
Gender [units: participants]
Female	134	147	281
Male	86	83	169
Race/Ethnicity, Customized [units: Participants]
Caucasian	196	204	400
Black	10	6	16
Asian	1	2	3
Other	13	18	31

[1]	Of the 452 subjects randomized, 2 subjects were excluded from the intent-to-treat (ITT) population: 1 subject had no baseline data recorded, and 1 subject was randomized twice. Baseline demographics were calculated on the ITT population of 450 participants.

Outcome Measures

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1. Primary:

Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score [ Time Frame: 10 weeks ]

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2. Secondary:

Patient Global Impression of Change (PGIC) [ Time Frame: 10 weeks ]

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3. Secondary:

Clinical Global Impression of Change (CGIC) [ Time Frame: 10 weeks ]

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4. Secondary:

Average Daily Sleep Interference Score [ Time Frame: 10 weeks ]

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5. Other Pre-specified:

Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score [ Time Frame: 10 weeks ]

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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: The PI agree that the sponsor shall have the right to the first publication of the results of the study which is intended to be joint, multi-center publication. Following the first publication, the PI may publish data or results from the study, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the data of the proposed publication.Sponsor may remove any information that is considered confidential and or proprietary other than study data.

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: Head of R&D
Organization: Depomed
phone: 650-462-5900 ext 108
e-mail: msweeney@depomed.com

No publications provided

Responsible Party:	Depomed
ClinicalTrials.gov Identifier:	NCT00636636 History of Changes
Obsolete Identifiers:	NCT01465321
Other Study ID Numbers:	81-0062
Study First Received:	February 21, 2008
Results First Received:	October 13, 2011
Last Updated:	January 27, 2012
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration