Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01220180

First received: October 7, 2010

Last updated: November 3, 2011

Last verified: November 2011

History of Changes

Results First Received: November 3, 2011

Study Type:	Observational
Study Design:	Observational Model: Ecologic or Community; Time Perspective: Prospective
Conditions:	Epilepsy Neuropathic Pain Fibromyalgia Post-market Surveillance
Intervention:	Drug: pregabalin (Lyrica)

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pregabalin	Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.

Participant Flow: Overall Study

	Pregabalin
STARTED	4175
Treated	4174
COMPLETED	3968
NOT COMPLETED	207
Lost to Follow-up	76
Unspecified	72
Adverse Event	35
Lack of Efficacy	22
Death	1
Randomized but not treated	1

Baseline Characteristics

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Reporting Groups

	Description
Pregabalin: Epilepsy	Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
Pregabalin: Neuropathic Pain	Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
Pregabalin: Fibromyalgia	Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
Total	Total of all reporting groups

Baseline Measures

	Pregabalin: Epilepsy	Pregabalin: Neuropathic Pain	Pregabalin: Fibromyalgia	Total
Number of Participants [units: participants]	787	3266	121	4174
Age, Customized [units: Participants]
Less than 20 years	37	2	0	39
20 to 29 years	192	26	3	221
30 to 39 years	158	105	8	271
40 to 49 years	146	409	30	585
50 to 59 years	119	840	36	995
60 to 69 years	89	1094	28	1211
Greater than and equal to 70 years	46	790	16	852
Gender [units: Participants]
Female	364	1689	83	2136
Male	423	1577	38	2038

Outcome Measures

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1. Primary:

Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population [ Time Frame: Baseline through Week 12 ]

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2. Primary:

Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population [ Time Frame: Baseline through Week 12 ]

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3. Primary:

Percentage of Participants With Improvement in Seizure Frequency in ITT Population [ Time Frame: Baseline through Week 12 ]

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4. Primary:

Percentage of Participants With Improvement in Seizure Frequency in PP Population [ Time Frame: Baseline through Week 12 ]

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5. Primary:

Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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6. Primary:

Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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7. Primary:

Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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8. Primary:

Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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9. Secondary:

Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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10. Secondary:

Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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11. Secondary:

Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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12. Secondary:

Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6 [ Time Frame: Baseline and Week 6 ]

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13. Secondary:

Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population [ Time Frame: Week 6 ]

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14. Secondary:

Number of Participants With CGIC Scale for NeP in PP Population [ Time Frame: Week 6 ]

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15. Secondary:

Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population [ Time Frame: Week 6 ]

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16. Secondary:

Number of Participants With PGIC Scale for NeP in PP Population [ Time Frame: Week 6 ]

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17. Secondary:

Number of Participants With CGIC Scale for Fibromyalgia in ITT Population [ Time Frame: Week 6 ]

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18. Secondary:

Number of Participants With CGIC Scale for Fibromyalgia in PP Population [ Time Frame: Week 6 ]

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19. Secondary:

Number of Participants With PGIC Scale for Fibromyalgia in ITT Population [ Time Frame: Week 6 ]

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20. Secondary:

Number of Participants With PGIC Scale for Fibromyalgia in PP Population [ Time Frame: Week 6 ]

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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
It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.

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:	NCT01220180 History of Changes
Other Study ID Numbers:	A0081138
Study First Received:	October 7, 2010
Results First Received:	November 3, 2011
Last Updated:	November 3, 2011
Health Authority:	Korea: Korean Food and Drug Administration

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