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Trial record 2 of 22 for:    Open Studies | "Neuralgia, Postherpetic"
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Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)

This study is currently recruiting participants.
Verified April 2013 by Purdue Pharma LP
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01688947
First received: September 17, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  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:

Drug Information available for: Pregabalin
U.S. FDA Resources

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 ]

Estimated Enrollment: 144
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated 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 80 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688947

Contacts
Contact: Study Coordinator 1-877-333-0076

  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: April 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Pain
Neuralgia, Postherpetic

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neuralgia
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

ClinicalTrials.gov processed this record on May 16, 2013