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

NCT01688947 | Completed Phase 2

• 1 other identifier: VND2002
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Postherpetic Neuralgia; Pain

Keywords

Pain; Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (1)

• "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)

  Week 4

Secondary Outcomes (4)

• mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6)

  Week 4

• Neuropathic Pain Symptom Inventory (NPSI)

  Week 4

• Patient Global Impression of Change (PGIC)

  Week 4

• Supplemental Analgesic Medication Use

  Over 4 weeks

Study Arms (4)

V116517 - 50 mg

EXPERIMENTAL

V116517 50-mg tablets

Drug: V116517 50-mg tablets; Drug: Placebo

V116517 - 30 mg

EXPERIMENTAL

V116517 30-mg tablets

Drug: V116517 30-mg tablets; Drug: Placebo

Pregabalin

ACTIVE COMPARATOR

Pregabalin capsules

Drug: Pregabalin capsules; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

V116517 50-mg tablets DRUG

Taken orally twice daily

V116517 - 50 mg

V116517 30-mg tablets DRUG

Taken orally twice daily

V116517 - 30 mg

Pregabalin capsules DRUG

1-2 capsules taken orally twice daily

Pregabalin

Placebo DRUG

Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily

Placebo; Pregabalin; V116517 - 30 mg; V116517 - 50 mg

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition.
• 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.

You may not qualify if:

• 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.
• Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
• Subjects with a recent history of seizure within the past 5 years.
• Subjects who use opioids more than 4 days per week.
• 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.
• Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
• 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.
• Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (28)

Investigational Site

Tucson, Arizona, 85704, United States

Location

Investigational Site

La Jolla, California, 92037-7651, United States

Location

Investigational Site

North Hollywood, California, 91606, United States

Location

Investigational Site

Boca Raton, Florida, 33486, United States

Location

Investigational Site

Bradenton, Florida, 34205, United States

Location

Investigational Site

DeLand, Florida, 32720, United States

Location

Investigational Site

Fort Myers, Florida, 33916, United States

Location

Investigational Site

Lynn Haven, Florida, 32444, United States

Location

Investigational Site

North Miami, Florida, 33161, United States

Location

Investigational Site

Orlando, Florida, 32806, United States

Location

Investigational Site

Oviedo, Florida, 32765, United States

Location

Investigational Site

Palm Beach Gardens, Florida, 33410, United States

Location

Investigational Site

Sarasota, Florida, 34233, United States

Location

Investigational Site

St. Petersburg, Florida, 33716, United States

Location

Investigational Site

Sunrise, Florida, 33351, United States

Location

Investigational Site

Decatur, Georgia, 30033, United States

Location

Investigational Site

Chicago, Illinois, 60634, United States

Location

Investigational Site

Prairie Village, Kansas, 66206, United States

Location

Investigational Site

New Bedford, Massachusetts, 02740, United States

Location

Investigational Site

Bay City, Michigan, 48706, United States

Location

Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

Investigational Site

Pinconning, Michigan, 48650, United States

Location

Investigational Site

Las Vegas, Nevada, 89123, United States

Location

Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

Investigational Site

Charlotte, North Carolina, 28204, United States

Location

Investigational Site

Raleigh, North Carolina, 27609, United States

Location

Investigational Site

Austin, Texas, 78731, United States

Location

Investigational Site

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Pain

Interventions

4-(3-chloro-5-(1,2-dihydroxyethyl)-2-pyridyl)-N-(5-(trifluoromethyl)-2-pyridyl)-3,6-dihydro-2H-pyridine-1-carboxamide; Pregabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

US (28)