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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01688947
First received: September 17, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia
Pain
Drug: V116517 50-mg tablets
Drug: V116517 30-mg tablets
Drug: Pregabalin capsules
Drug: Placebo
Phase 2

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 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)

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Supplemental Analgesic Medication Use [ Time Frame: Over 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V116517 - 50 mg
V116517 50-mg tablets
Drug: V116517 50-mg tablets
Taken orally twice daily
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Experimental: V116517 - 30 mg
V116517 30-mg tablets
Drug: V116517 30-mg tablets
Taken orally twice daily
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Active Comparator: Pregabalin
Pregabalin capsules
Drug: Pregabalin capsules
1-2 capsules taken orally twice daily
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688947

  Show 28 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
  More Information

No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01688947     History of Changes
Other Study ID Numbers: VND2002
Study First Received: September 17, 2012
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Pain
Neuralgia, Postherpetic

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Pregabalin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014