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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Diabetic Neuropathy

Neuralgia, Postherpetic

Painful Small-Fiber Neuropathy

Idiopathic Distal Sensory Polyneuropathy

Treatments

Drug: Comparator: Placebo (unspecified)

Drug: Comparator: pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00570310

2007_650

0000-072

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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