Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Neuropathic Pain Syndrome Patient Study
This study is ongoing, but not recruiting participants.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00570310
  Purpose

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 Intervention Phase
Neuralgia, Postherpetic
Diabetic Neuropathy
Painful Small-Fiber Neuropathy
Idiopathic Distal Sensory Polyneuropathy
Drug: Comparator: pregabalin
Drug: Comparator: Placebo (unspecified)
Phase I

MedlinePlus related topics: Diabetic Nerve Problems Shingles
Drug Information available for: Pregabalin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:
  • Daily evening patient reported pain intensity scores [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 'Time to efficacy failure' during the randomized withdrawal portion of the study [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2007
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
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 po). Duration of Treatment: 6 Weeks
B: Placebo Comparator
Patients in Group B will be treated with placebo.
Drug: Comparator: Placebo (unspecified)
pregabalin Pbo (up to 600 mg/day po). Duration of Treatment: 6 Weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570310

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2007_650, 072
Study First Received: December 7, 2007
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00570310  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neuralgia, Postherpetic
Diabetic Neuropathies
Neuralgia
Polyneuropathies
Diabetes Mellitus
Pregabalin
Endocrine System Diseases
Pain
Signs and Symptoms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Neurologic Manifestations
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009