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

Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688947
• Other study ID #: VND2002
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2012
• Last updated: May 9, 2014
• Start date: September 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Key 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.

Key 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.

Other protocol specific inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuralgia, Postherpetic
• Pain
• Postherpetic Neuralgia

Intervention

Drug:
• V116517 50-mg tablets
Taken orally twice daily
• V116517 30-mg tablets
Taken orally twice daily
• Pregabalin capsules
1-2 capsules taken orally twice daily
• Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily

Locations

Country	Name	City	State
United States	Investigational Site	Albuquerque	New Mexico
United States	Investigational Site	Austin	Texas
United States	Investigational Site	Bay City	Michigan
United States	Investigational Site	Bingham Farms	Michigan
United States	Investigational Site	Boca Raton	Florida
United States	Investigational Site	Bradenton	Florida
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Decatur	Georgia
United States	Investigational Site	Deland	Florida
United States	Investigational Site	Fort Myers	Florida
United States	Investigational Site	La Jolla	California
United States	Investigational Site	Las Vegas	Nevada
United States	Investigational Site	Lynn Haven	Florida
United States	Investigational Site	New Bedford	Massachusetts
United States	Investigational Site	North Hollywood	California
United States	Investigational Site	North Miami	Florida
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Oviedo	Florida
United States	Investigational Site	Palm Beach Gardens	Florida
United States	Investigational Site	Pinconning	Michigan
United States	Investigational Site	Prairie Village	Kansas
United States	Investigational Site	Raleigh	North Carolina
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	Sarasota	Florida
United States	Investigational Site	St. Petersburg	Florida
United States	Investigational Site	Sunrise	Florida
United States	Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)		Week 4	No
Secondary	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	No
Secondary	Neuropathic Pain Symptom Inventory (NPSI)		Week 4	No
Secondary	Patient Global Impression of Change (PGIC)		Week 4	No
Secondary	Supplemental Analgesic Medication Use		Over 4 weeks	No