Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia

July 8, 2015 updated by: Cubist Pharmaceuticals LLC

A Phase 2A, Randomized, Blinded, Placebo- and Active-controlled, 2-Period Crossover Study to Assess the Analgesic Efficacy, Safety, and Tolerability of ADL5747 in Subjects With Postherpetic Neuralgia

The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • West Palm Beach, Florida, United States, 33407-2450
        • Laszlo J. Mate, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key inclusion Criteria:

  • have a diagnosis of PHN (defined as pain present for at least 3 months after the healing of herpes zoster rash; there is no upper limit on the duration of PHN)
  • have an average daily pain score of at least 4 on the numeric pain rating scale (0-10) at the start of baseline week for Treatment Period 1 (Day -7) through the start of the first week of Treatment Period 1 (Day 1)
  • be willing and able to understand and comply with protocol requirements, dietary and dosing regimens, and other protocol instructions and restrictions (for example, forgo use of their normal pain medication and other protocol specified prohibited medications for the duration of the study)
  • for male participants, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved and deemed highly effective by the United States Food and Drug Administration (FDA) from the first dose of study medication through 30 days after the last dose of study medication on Day 49
  • for female participants of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive approved and deemed highly effective by the FDA from the first dose of study medication through 30 days after the last dose of study medication on Day 49 and have negative results on a serum pregnancy test during the start of the screening period to obtain informed consent and determine eligibility for the study (Day -37 to -14) and on a urine pregnancy test during the start of the first week of Treatment Period 1 (Day 1) (women who are surgically sterile [for example, hysterectomy, tubal ligation] or postmenopausal [if ≥ 55 years old, no menses for at least 2 years; if < 55 years old, follicle stimulating hormone concentrations within the postmenopausal range of > 40 milli-International Units per milliliter (mIU/mL) and 17 β estradiol levels of < 37 picograms per milliliter (pg/mL)] are also eligible to participate)

Key Exclusion Criteria:

  • be pregnant or lactating
  • have significant skin lesions that could interfere with pain assessment
  • have a history of seizures or a history of abnormal electroencephalographic results at any time (participants with a history of febrile seizures before the age of 6 years may be enrolled)
  • have had previous neurolytic or neurosurgical therapy for PHN
  • have had a treatment that included local anesthetic nerve blocks within 30 days before the start of the baseline week for Treatment Period 1 (Day -7)
  • have any other type of pain that may impair the self-assessment of pain due to PHN
  • have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, hematologic, cardiovascular, metabolic, gastrointestinal, neurologic, psychiatric, or other condition that would preclude participation in the study
  • have an active malignancy of any type (participants with a history of successfully treated malignancy > 5 years before the scheduled first dose of study medication and participants with treated basal or squamous cell cancer may be enrolled)
  • have a medical history or condition that may interfere with drug absorption (for example, stomach resection)
  • be currently using protocol specified prohibited medications in the absence of appropriate washout
  • be currently taking moderate or strong inhibitors or inducers of cytochrome P450-3A (CYP3A) or inhibitors of P glycoprotein transporters
  • have an estimated glomerular filtration rate (GFR) that is less than or equal to 60 mL/min calculated by the Cockcroft Gault equation or have alanine aminotransferase and/or aspartate aminotransferase levels that are at least 2 times the upper limit of normal
  • have a history of substance abuse or dependence within the previous 5 years, including alcohol or positive results on the urine drug screen at start of screening period, start of baseline week, or start of the first week of Treatment Period 1 (Day -37 to Day 1); participants may be enrolled if positive results are due to medication(s) prescribed for the participant and permitted by the protocol
  • have a history of suicide attempts or be judged clinically to be at serious risk of suicide
  • have a score of more than 29 on the Beck Depression Inventory-II at start of screening period (Day -37 to Day -14)
  • have a history of allergy to acetaminophen (the rescue medication for this study)
  • have a history of intolerance to pregabalin or documented failure to respond to a maximally tolerated dose of pregabalin
  • have ever received the investigational drug ADL5747 or have participated in any clinical study involving an investigational product in which they received that product within 30 days before the scheduled administration of study medication for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADL5747
ADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
Drug: Placebo
Drug: ADL5747
Placebo Comparator: Placebo

Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.

Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
Drug: Placebo
Active Comparator: Pregabalin
Pregabalin administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
Drug: Placebo
Drug: Pregabalin
Other Names:
  • Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)
Time Frame: Baseline, Week 2 of Treatment Period 1 or 2
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.
Baseline, Week 2 of Treatment Period 1 or 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cubist Pharmaceuticals LLC

Collaborators

Pfizer

Investigators

  • Study Director: Wei Du, MD, Cubist Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40CL234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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