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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570310
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : February 5, 2010
Last Update Posted : May 7, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

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

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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00570310

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00570310     History of Changes
Other Study ID Numbers: 0000-072
First Posted: December 10, 2007    Key Record Dates
Results First Posted: February 5, 2010
Last Update Posted: May 7, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Small Fiber Neuropathy
Diabetic Neuropathies
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs