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

Primary Purpose

Postherpetic Neuralgia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADL5747
Placebo
Pregabalin
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring pain, delta opioid receptor agonist

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laszlo J. Mate, MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

ADL5747

Placebo

Pregabalin

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2010
Last Updated
July 8, 2015
Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01058642
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
pain, delta opioid receptor agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADL5747
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ADL5747
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Primary Outcome Measure Information:
Title
Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)
Description
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.
Time Frame
Baseline, Week 2 of Treatment Period 1 or 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Du, MD
Organizational Affiliation
Cubist Pharmaceuticals LLC
Official's Role
Study Director
Facility Information:
Facility Name
Laszlo J. Mate, MD
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-2450
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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