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Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01332149
First received: April 7, 2011
Last updated: June 27, 2014
Last verified: June 2014

April 7, 2011
June 27, 2014
July 2011
April 2014   (final data collection date for primary outcome measure)
Endpoint mean pain score based on the pain scores from the subject's daily pain rating scale [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01332149 on ClinicalTrials.gov Archive Site
  • Weekly mean pain scores from the subject's daily pain rating scale [ Time Frame: End of week 1, 2, 3, 4, 5, 6, 7, 8, 9 ] [ Designated as safety issue: No ]
  • Weekly mean sleep interference scores from the subject's daily sleep interference scale [ Time Frame: End of week 1, 2, 3, 4, 5, 6, 7, 8, 9 ] [ Designated as safety issue: No ]
  • Responder rates with at least a 30% reduction from baseline in weekly mean pain score [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Short-Form McGill Pain Questionnaire at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Pain Visual Analogue Scale at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Medical Outcomes Study -Sleep Scale at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • The Subject Global Impression of Change at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • The Clinical Global Impression of Change at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Hospital Anxiety and Depression Scale at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
An 11-week Randomized, Double-blind, Multi Center, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Pain Associated With Diabetic Peripheral Neuropathy.

Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.

This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
  • Drug: Pregabalin

    Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.

    At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.

  • Drug: Placebo matched with pregabalin
    Subject will take placebo matched with pregabalin twice a day.
  • Experimental: 300 mg/day pregabalin (Lyrica)
    Patient take pregabalin capsule twice a day
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo matched with pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
626
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects aged 18 years or older
  • Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
  • At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
  • Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Women of childbearing potential are willing to use contraception during study.

Exclusion Criteria:

  • Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
  • Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
  • Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01332149
A0081265
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

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