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Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01279850
First received: January 18, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes

January 18, 2011
April 29, 2013
May 2011
September 2014   (final data collection date for primary outcome measure)
  • The incidence of adverse drug reactions for long term use. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction) for long term use. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy rate for the patients of NEUROPATHIC PAIN include POSTHERPETIC NEURALGIA for long term use. [ Time Frame: MAX 104 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01279850 on ClinicalTrials.gov Archive Site
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Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
Special Investigation Of Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)

The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Patients who fulfill criteria below:

  1. Patients who have previously enrolled in A0081261.
  2. Patients who have been administered Lyrica for more than 52 weeks.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

The patients whom an investigator involving A0081262 prescribes the Lyrica capsule.

And the patients who are administered Lyrica for over 52 weeks (MAX 104 weeks).
Neuralgia
Drug: Pregabalin (Lyrica) capsule
Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily".
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
Pregabalin (Lyrica) capsule
Patients administered "Pregabalin capsule".
Intervention: Drug: Pregabalin (Lyrica) capsule
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Lyrica.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01279850
A0081262
No
Pfizer
Pfizer
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Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP