To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.

Condition	Intervention	Phase
Diabetic Diabetic Neuropathies Neuralgia	Drug: Administration	Phase III

Further Study Details: 

Primary Outcomes: Endpoint Mean Pain Scores from DPRS
Secondary Outcomes: •Proportion of 30% Responders (With Respect to Pain Scores) at Endpoint.; •Proportion of 50% Responders (With Respect to Pain Scores) at Endpoint.; •Weekly Mean Pain Score from DPRS.; •Weekly Mean Sleep Interference Score from Daily Sleep Interference Scale
Expected Total Enrollment:  234

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of peripheral neuropathic pain syndrome, including DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
• Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of > 4 over the 7 days prior to Visit 2 (randomization).

Exclusion Criteria:

• Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
• Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).

Please refer to this study by ClinicalTrials.gov identifier  NCT00141219

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A0081037
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141219
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
ClinicalTrials.gov processed this record on 2005-09-06