Pregabalin Peripheral Neuropathic Pain Study

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00141219

First received: August 30, 2005

Last updated: September 23, 2009

Last verified: September 2009

History of Changes

Results First Received: December 19, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Diabetic Neuropathies Neuralgia
Interventions:	Drug: pregabalin 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
Study Initiation and Completion Dates: 27 December 2005 to 28 December 2007; 10 study centers in Korea

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
241 subjects were assigned to study treatment; one subject was randomized but did not receive any study treatment with the reason ‘Did not meet entrance criteria’.

Reporting Groups

	Description
Pregabalin	Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
Placebo	Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.

Participant Flow: Overall Study

	Pregabalin	Placebo
STARTED	162	78
COMPLETED	138	62
NOT COMPLETED	24	16
Protocol violations	5	4
Adverse Event	8	6
Lack of Efficacy	5	4
Withdrawal by Subject	6	2

Baseline Characteristics

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Reporting Groups

	Description
Pregabalin	Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
Placebo	Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
Total	Total of all reporting groups

Baseline Measures

	Pregabalin	Placebo	Total
Number of Participants [units: participants]	162	78	240
Age [units: years] Mean ± Standard Deviation	59.7 ± 10.8	61.3 ± 12.9	60.2 ± 11.5
Gender [units: participants]
Female	83	46	129
Male	79	32	111

Outcome Measures

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1. Primary:

Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]

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2. Secondary:

Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]

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3. Secondary:

Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores) [ Time Frame: Endpoint- Week 8 or Early Discontination ]

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4. Secondary:

Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score [ Time Frame: Weeks 1 to 8 ]

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5. Secondary:

Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score [ Time Frame: Weeks 1 to 8 ]

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6. Secondary:

Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS). [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]

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7. Secondary:

Mean Sleep Score as Computed by DSIS. [ Time Frame: Weeks 1 to 8 ]

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8. Secondary:

Medical Outcome Study (MOS) Sleep Disturbance [ Time Frame: Week 8 ]

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9. Secondary:

Medical Outcome Study (MOS) Snoring Score [ Time Frame: Week 8 ]

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10. Secondary:

Medical Outcome Study (MOS) Awaken Short of Breath or Headache [ Time Frame: Week 8 ]

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11. Secondary:

Medical Outcome Study (MOS) Sleep Quantity [ Time Frame: Week 8 ]

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Measure Type	Secondary
Measure Title	Medical Outcome Study (MOS) Sleep Quantity
Measure Description	MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).
Time Frame	Week 8
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.

Reporting Groups

	Description
Pregabalin	Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
Placebo	Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.

Measured Values

	Pregabalin	Placebo
Number of Participants Analyzed [units: participants]	158	75
Medical Outcome Study (MOS) Sleep Quantity [units: score on scale] Least Squares Mean ( 95% Confidence Interval )	6.46 ( 6.25 to 6.67 )	6.02 ( 5.72 to 6.33 )

Statistical Analysis 1 for Medical Outcome Study (MOS) Sleep Quantity

Groups ^[1]	All groups
Method ^[2]	General Linear Model
P Value ^[3]	0.018
Mean Difference (Final Values) ^[4]	0.44
Standard Error of the mean	± 0.182
95% Confidence Interval	( 0.08 to 0.80 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8 Sleep Quantity Pregabalin minus Placebo
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated from general linear model with treatment and center as factors and baseline value as a covariate.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	All statistical testing was 2-sided and was conducted at the 5% level of significance.
[4]	Other relevant estimation information:
	No text entered.

12. Secondary:

Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep [ Time Frame: Week 8 ]

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13. Secondary:

Medical Outcome Study (MOS) Sleep Adequacy [ Time Frame: Week 8 ]

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14. Secondary:

Medical Outcome Study (MOS) Somnolence [ Time Frame: Week 8 ]

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15. Secondary:

Medical Outcome Study (MOS) Overall Sleep Problems Index [ Time Frame: Week 8 ]

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16. Secondary:

Euro Quality of Life (QOL) (EQ-5D) Utility Score [ Time Frame: Week 8 ]

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17. Secondary:

Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Week 8 ]

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18. Secondary:

Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score [ Time Frame: Week 8 ]

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19. Secondary:

Hospital Anxiety and Depression Scale- Depression (HADS-D) Score [ Time Frame: Week 8 ]

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20. Secondary:

Patient Global Impression of Change (PGIC) [ Time Frame: Week 8 ]

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21. Secondary:

Clinical Global Impression of Change (CGIC) [ Time Frame: Week 8 ]

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22. Secondary:

Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score [ Time Frame: Weeks 1 to 8 ]

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23. Other Pre-specified:

Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]

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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 months 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 Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00141219 History of Changes
Other Study ID Numbers:	A0081037
Study First Received:	August 30, 2005
Results First Received:	December 19, 2008
Last Updated:	September 23, 2009
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

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