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

Primary Purpose

Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Comparator: pregabalin

Comparator: Placebo (unspecified)

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.

Patients in Group B will be treated with placebo.

Outcomes

Primary Outcome Measures

Daily Evening Patient Reported Pain Intensity Scores

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 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)

Full Information

NCT ID

NCT00570310

First Posted

December 7, 2007

Last Updated

April 20, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00570310

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Patients in Group B will be treated with placebo.

Intervention Type

Drug

Intervention Name(s)

Comparator: pregabalin

Intervention Description

pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Intervention Type

Drug

Intervention Name(s)

Comparator: Placebo (unspecified)

Intervention Description

pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Primary Outcome Measure Information:

Title

Daily Evening Patient Reported Pain Intensity Scores

Description

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)

Time Frame

Baseline and 6 Weeks

Secondary Outcome Measure Information:

Title

'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study

Description

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)

Time Frame

6 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

21185118

Citation

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.

Results Reference

result

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

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