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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Cubist Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01058642
First received: January 27, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia
Drug: ADL5747
Drug: Placebo
Drug: Pregabalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

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) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: January 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADL5747
ADL5747 150 mg twice daily
Drug: ADL5747
ADL5747 150 mg twice daily for 2 weeks
Placebo Comparator: Placebo
twice daily
Drug: Placebo
twice daily
Active Comparator: Pregabalin
Pregabalin 150 mg twice daily
Drug: Pregabalin
pregabalin 75 mg twice daily for the first 3 days, increased to 150 mg twice daily for the last 11 days of the 2 week treatment period, followed by a dose of pregabalin 75 mg twice daily for 3 days as a taper period
Other Name: Lyrica

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) for Visits 2 and 3
  • be willing and able to understand and comply with protocol requirements, dietary and dosing regimens, and other protocol instructions and restrictions (eg, forgo use of their normal pain medication and other protocol specified prohibited medications for the duration of the study)
  • for male subjects, 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 subjects 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 Visit 1 and on a urine pregnancy test during Visit 3 (women who are surgically sterile [eg, 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 mIU/mL and 17 β estradiol levels of < 37 pg/mL] are also eligible to participate)

Key exclusion Criteria:

  • be pregnant
  • 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 (subjects 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 Visit 2 (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 (subjects with a history of successfully treated malignancy > 5 years before the scheduled first dose of study medication and subjects with treated basal or squamous cell cancer may be enrolled)
  • have a medical history or condition that may interfere with drug absorption (eg, 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 Visit 1, 2, or 3; subjects may be enrolled if positive results are due to medication(s) prescribed for the subject 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 Visit 1
  • 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
  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: NCT01058642

Locations
United States, Florida
Laszlo J. Mate, MD
West Palm Beach, Florida, United States, 33407-2450
Sponsors and Collaborators
Cubist Pharmaceuticals
Pfizer
Investigators
Study Director: Wei Du, MD Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Wei Du, MD, Adolor Corporation
ClinicalTrials.gov Identifier: NCT01058642     History of Changes
Other Study ID Numbers: 40CL234
Study First Received: January 27, 2010
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
pain
delta opioid receptor agonist

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
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 October 16, 2014