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

NCT ID: NCT00570310

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-09-30

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.

Group Type: ACTIVE_COMPARATOR

Comparator: pregabalin

Intervention Type: DRUG

pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

B

Patients in Group B will be treated with placebo.

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type: DRUG

pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Interventions

Comparator: pregabalin

pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Intervention Type: DRUG

Comparator: Placebo (unspecified)

pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Hewitt DJ, Ho TW, Galer B, Backonja M, Markovitz P, Gammaitoni A, Michelson D, Bolognese J, Alon A, Rosenberg E, Herman G, Wang H. Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain. Pain. 2011 Mar;152(3):514-521. doi: 10.1016/j.pain.2010.10.050. Epub 2010 Dec 23.

Reference Type: RESULT

PMID: 21185118 (View on PubMed)

Other Identifiers

2007_650

Identifier Type: -

Identifier Source: secondary_id

0000-072

Identifier Type: -

Identifier Source: org_study_id