Neuropathic Pain Syndrome Patient Study (MK0000-072)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00570310
First received: December 7, 2007
Last updated: April 28, 2011
Last verified: April 2011
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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:
Genetics Home Reference related topics:
small fiber neuropathy
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Merck:
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 More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00570310 History of Changes |
| Other Study ID Numbers: | MK-0000-072, 2007_650 |
| Study First Received: | December 7, 2007 |
| Results First Received: | January 13, 2010 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Neuralgia Neuralgia, Postherpetic Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Pain |
Neurologic Manifestations Signs and Symptoms Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 21, 2013