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

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Purdue Pharma

Status and phase

Completed
Phase 2

Conditions

Postherpetic Neuralgia
Pain

Treatments

Drug: V116517 50-mg tablets
Drug: Placebo
Drug: V116517 30-mg tablets
Drug: Pregabalin capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT01688947
VND2002

Details and patient eligibility

About

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

Enrollment

105 patients

Sex

All

Ages

21 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 4 patient groups, including a placebo group

V116517 - 50 mg
Experimental group
Description:
V116517 50-mg tablets
Treatment:
Drug: Placebo
Drug: V116517 50-mg tablets
V116517 - 30 mg
Experimental group
Description:
V116517 30-mg tablets
Treatment:
Drug: V116517 30-mg tablets
Drug: Placebo
Pregabalin
Active Comparator group
Description:
Pregabalin capsules
Treatment:
Drug: Pregabalin capsules
Drug: Placebo
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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