A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00394901

First received: October 31, 2006

Last updated: February 26, 2010

Last verified: February 2010

History of Changes

Results First Received: November 7, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment
Condition:	Neuralgia, Postherpetic
Interventions:	Drug: Placebo Drug: Pregabalin

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
Fifty (50) centers in Japan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a 1-week baseline phase, subjects were stratified into 1 of 2 strata based on their creatinine clearance (CLcr) values (Low, 30 <CLcr <=60 mL/min or Normal, CLcr > 60 mL/min) and then equally randomized into 1 of 4 treatment groups.

Reporting Groups

	Description
Placebo	During a 13-week double-blind phase, subjects received matching placebo.
Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Participant Flow for 2 periods

Period 1: Baseline Phase

	Placebo	Pregabalin 150 mg/Day	Pregabalin 300 mg/Day	Pregabalin 600 mg/Day
STARTED	98 ^[1]	87 ^[1]	90 ^[1]	97 ^[1]
COMPLETED	98	87	89	97
NOT COMPLETED	0	0	1	0
Protocol Violation	0	0	1	0

[1]	Subjects randomized

Period 2: Double-blind Phase

	Placebo	Pregabalin 150 mg/Day	Pregabalin 300 mg/Day	Pregabalin 600 mg/Day
STARTED	98 ^[1]	87 ^[1]	89 ^[1]	97 ^[1]
COMPLETED	83	73	71	70
NOT COMPLETED	15	14	18	27
Adverse Event	5	7	16	20
Lack of Efficacy	6	4	1	3
Withdrawal by Subject	2	0	0	0
Lost to Follow-up	0	0	0	1
Protocol Violation	0	0	0	1
Death	1	0	0	0
Subject's Personal Reason	1	0	0	1
Lack of Compliance	0	3	0	0
Entry into another study was found	0	0	1	0
Found not to meet entrance criteria	0	0	0	1

[1]	Subjects treated with the study drug.

Baseline Characteristics

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Reporting Groups

	Description
Placebo	During a 13-week double-blind phase, subjects received matching placebo.
Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Pregabalin 150 mg/Day	Pregabalin 300 mg/Day	Pregabalin 600 mg/Day	Total
Number of Participants [units: participants]	98	87	89	97	371
Age [units: years] Mean ± Standard Deviation	71.1 ± 8.6	70.2 ± 9.2	70.9 ± 9.8	68.4 ± 12.5	70.1 ± 10.2
Age, Customized [units: participants]
<18 years	0	0	0	0	0
Between 18 and 44 years	2	1	2	6	11
Between 45 and 64 years	12	17	15	20	64
>=65 years	84	69	72	71	296
Gender [units: participants]
Female	41	44	44	44	173
Male	57	43	45	53	198
Region of Enrollment [units: participants]
Japan	98	87	89	97	371

Outcome Measures

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1. Primary:

Mean Pain Scores at Endpoint [ Time Frame: Week13/discontinuation ]

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2. Primary:

Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations [ Time Frame: Week13/discontinuation ]

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3. Primary:

Number of Responders [ Time Frame: Week13/discontinuation ]

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4. Primary:

Mean Pain Scores at Week 1 [ Time Frame: Week 1 ]

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5. Primary:

Mean Pain Scores at Week 2 [ Time Frame: Week 2 ]

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6. Primary:

Mean Pain Scores at Week 3 [ Time Frame: Week 3 ]

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7. Primary:

Mean Pain Scores at Week 4 [ Time Frame: Week4 ]

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8. Primary:

Mean Pain Scores at Week 5 [ Time Frame: Week 5 ]

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9. Primary:

Mean Pain Scores at Week 6 [ Time Frame: Week 6 ]

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10. Primary:

Mean Pain Scores at Week 7 [ Time Frame: Week 7 ]

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11. Primary:

Mean Pain Scores at Week 8 [ Time Frame: Week 8 ]

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12. Primary:

Mean Pain Scores at Week 9 [ Time Frame: Week 9 ]

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13. Primary:

Mean Pain Scores at Week 10 [ Time Frame: Week 10 ]

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14. Primary:

Mean Pain Scores at Week 11 [ Time Frame: Week 11 ]

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15. Primary:

Mean Pain Scores at Week 12 [ Time Frame: Week 12 ]

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16. Primary:

Mean Pain Scores at Week 13 [ Time Frame: Week 13 ]

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17. Secondary:

Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]

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18. Secondary:

Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]

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19. Secondary:

Endpoint Total Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]

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20. Secondary:

Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]

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21. Secondary:

Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]

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22. Secondary:

Mean Sleep Interference Scores at Endpoint [ Time Frame: Week13/discontinuation ]

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23. Secondary:

Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance [ Time Frame: Week13/discontinuation ]

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24. Secondary:

Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring [ Time Frame: Week13/discontinuation ]

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25. Secondary:

Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache [ Time Frame: Week13/discontinuation ]

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26. Secondary:

Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep [ Time Frame: Week13/discontinuation ]

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27. Secondary:

Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy [ Time Frame: Week13/discontinuation ]

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28. Secondary:

Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence [ Time Frame: Week13/discontinuation ]

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29. Secondary:

Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index [ Time Frame: Week13/discontinuation ]

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30. Secondary:

Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep [ Time Frame: Week13/discontinuation ]

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31. Secondary:

Endpoint Patient Global Impression Change [ Time Frame: Week13/discontinuation ]

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32. Secondary:

Endpoint Clinical Global Impression Change [ Time Frame: Week13/discontinuation ]

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33. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning [ Time Frame: Week13/discontinuation ]

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34. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical [ Time Frame: Week13/discontinuation ]

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35. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain [ Time Frame: Week13/discontinuation ]

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36. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception [ Time Frame: Week13/discontinuation ]

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37. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning [ Time Frame: Week13/discontinuation ]

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38. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional [ Time Frame: Week13/discontinuation ]

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39. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: Vitality [ Time Frame: Week13/discontinuation ]

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40. Secondary:

Endpoint Short-Form 36-Item Health Survey Scores: Mental Health [ Time Frame: Week13/discontinuation ]

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41. Secondary:

Number of Patients Not Reporting Allodynia [ Time Frame: Week13/discontinuation ]

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42. Secondary:

Number of Patients Not Reporting Hyperalgesia [ Time Frame: Week13/discontinuation ]

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43. Secondary:

Mean Sleep Interference Scores at Week 1 [ Time Frame: week 1 ]

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44. Secondary:

Mean Sleep Interference Scores at Week 2 [ Time Frame: week 2 ]

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45. Secondary:

Mean Sleep Interference Scores at Week 3 [ Time Frame: week 3 ]

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46. Secondary:

Mean Sleep Interference Scores at Week 4 [ Time Frame: week 4 ]

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47. Secondary:

Mean Sleep Interference Scores at Week 5 [ Time Frame: week 5 ]

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48. Secondary:

Mean Sleep Interference Scores at Week 6 [ Time Frame: week 6 ]

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49. Secondary:

Mean Sleep Interference Scores at Week 7 [ Time Frame: week 7 ]

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50. Secondary:

Mean Sleep Interference Scores at Week 8 [ Time Frame: week 8 ]

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51. Secondary:

Mean Sleep Interference Scores at Week 9 [ Time Frame: week 9 ]

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52. Secondary:

Mean Sleep Interference Scores at Week 10 [ Time Frame: week 10 ]

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53. Secondary:

Mean Sleep Interference Scores at Week 11 [ Time Frame: week 11 ]

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54. Secondary:

Mean Sleep Interference Scores at Week 12 [ Time Frame: week 12 ]

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55. Secondary:

Mean Sleep Interference Scores at Week 13 [ Time Frame: week 13 ]

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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 <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info 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.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00394901 History of Changes
Other Study ID Numbers:	A0081120
Study First Received:	October 31, 2006
Results First Received:	November 7, 2008
Last Updated:	February 26, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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