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

• ClinicalTrials.gov Identifier: NCT00570310
• Recruitment Status: Completed
• First Posted: December 10, 2007
• Results First Posted: February 5, 2010
• Last Update Posted: May 7, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neuralgia, Postherpetic; Diabetic Neuropathy; Painful Small-Fiber Neuropathy; Idiopathic Distal Sensory Polyneuropathy	Drug: Comparator: pregabalin; Drug: Comparator: Placebo (unspecified)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug
• Study Start Date: December 2007
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A; Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.	Drug: Comparator: pregabalin; pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
Placebo Comparator: B; Patients in Group B will be treated with placebo.	Drug: Comparator: Placebo (unspecified); pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Outcome Measures

Primary Outcome Measures :

1. Daily Evening Patient Reported Pain Intensity Scores [ Time Frame: Baseline and 6 Weeks ]
   Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)

Secondary Outcome Measures :

1. 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study [ Time Frame: 6 Weeks ]
   Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00570310
• Other Study ID Numbers: 0000-072; 2007_650
• First Posted: December 10, 2007
• Results First Posted: February 5, 2010
• Last Update Posted: May 7, 2015
• Last Verified: April 2015

Additional relevant MeSH terms:

Neuralgia; Diabetic Neuropathies; Polyneuropathies; Small Fiber Neuropathy; Neuralgia, Postherpetic; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pregabalin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs