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COMPLETEDPHASE2

Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)

A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)

NCT01688947•Purdue Pharma LP

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.

Eligibility

Age

21 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition.
•2. Clinical diagnosis of PHN based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration.

Exclusion Criteria

•1. Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
•2. Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
•3. Subjects with a recent history of seizure within the past 5 years.
•4. Subjects who use opioids more than 4 days per week.
•5. Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
•6. Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
•7. PHN-pain-condition-specific exclusions:
•* Subjects who received pain-control interventions including neurolytic blocks or neurosurgical procedures to the affected nerve or spinal cord segment, spinal cord, stimulators, or neuraxial infusion pumps.
•8. Active-comparator-related exclusions:
•* Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.

Locations (28)

Investigational Site

Tucson, Arizona, United States

Investigational Site

La Jolla, California, United States

Investigational Site

North Hollywood, California, United States

Investigational Site

Boca Raton, Florida, United States

Investigational Site

Bradenton, Florida, United States

Investigational Site

DeLand, Florida, United States

Investigational Site

Fort Myers, Florida, United States

Investigational Site

Lynn Haven, Florida, United States

Investigational Site

North Miami, Florida, United States

Investigational Site

Orlando, Florida, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

March 1, 2014

Completion Date

April 1, 2014

Last Updated

May 12, 2014

Enrollment

105

ACTUAL participants

Conditions

Postherpetic NeuralgiaPain

Interventions

V116517 50-mg tablets

DRUG

V116517 30-mg tablets

DRUG

Pregabalin capsules

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)

Inclusion Criteria

Exclusion Criteria

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy

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