A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetic Neuropathy, Painful
Intervention:	Drug: pregabalin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-six (36) centers in Japan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with pain associated with diabetic peripheral neuropathy who had completed the 13-week treatment phase in the preceding study (Study A0081163: NCT00553475), without any treatment-related serious adverse events or any compliance problems were eligible for the study.

Reporting Groups

	Description
Pregabalin	Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.

Description

Pregabalin

Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.

Participant Flow: Overall Study

	Pregabalin
STARTED	123
COMPLETED	97
NOT COMPLETED	26
Adverse Event	19
Lack of Efficacy	3
Withdrawal by Subject	3
Physician Decision	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Pregabalin	Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.

Description

Pregabalin

Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.

Baseline Measures

	Pregabalin
Number of Participants [units: participants]	123
Age, Customized [units: participants]
< 18 years	0
18 - 44 years	6
45 - 64 years	71
>= 65 years	46
Age, Customized [units: years] Mean ± Standard Deviation	61.7 ± 10.0
Gender [units: participants]
Female	23
Male	100

Outcome Measures

Show All Outcome Measures

1. Primary:

Summary of Adverse Events [ Time Frame: 53 weeks ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores [ Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint) ]

Show Outcome Measure 6

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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:	Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00553280 History of Changes
Other Study ID Numbers:	A0081164
Study First Received:	November 2, 2007
Results First Received:	December 7, 2010
Last Updated:	April 22, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare