Phase 1 N=104 Randomized Double-blind Treatment

Neuropathic Pain Syndrome Patient Study (MK-0000-072)

Neuralgia, Postherpetic · Diabetic Neuropathy · Painful Small-Fiber Neuropathy · Idiopathic Distal Sensory Polyneuropathy

Bottom Line

View on ClinicalTrials.gov: NCT00570310 ↗

Enrolled (actual)

104

Serious AEs

1.0%

Results posted

Feb 2010

Primary outcome: Primary: Daily Evening Patient Reported Pain Intensity Scores — 0.14; 1.57 Units on a Scale — p=0.003

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Comparator: pregabalin (Drug); Comparator: Placebo (unspecified) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Daily Evening Patient Reported Pain Intensity Scores	0.14; 1.57	0.003 sig
SECONDARY 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	15.54; 7.87	<0.001 sig

Summary

The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.

Eligibility Criteria

Inclusion Criteria

Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
Patient is able to complete questionnaires in either English or Spanish
Patient is at least 18 years of age

Exclusion Criteria

Patient is either pregnant or breastfeeding
Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
Patient has a history of congestive heart failure
Patient has a seizure disorder
Patient has a history of drug and/or alcohol abuse within the past 1 year
Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain
Patient has had cancer (except basal cell carcinoma) within the past two years
Patient anticipates the need for surgery while participating in the study
Patient has a reported history of hepatitis B, C, or HIV infection
Patient has another type of pain that is more painful than the nerve pain
Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder
Patient is involved in litigation or receives worker's compensation related to nerve pain

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00570310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.