Trial record 6 of 7 for:    "small fiber neuropathy" OR "small nerve fiber neuropathy"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00570310
First received: December 7, 2007
Last updated: February 19, 2014
Last verified: February 2014
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Daily Evening Patient Reported Pain Intensity Scores [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    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:
  • 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    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)


Enrollment: 104
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570310

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00570310     History of Changes
Other Study ID Numbers: 0000-072, 2007_650
Study First Received: December 7, 2007
Results First Received: January 13, 2010
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Neuralgia, Postherpetic
Polyneuropathies
Erythromelalgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 14, 2014