Safety and Efficacy Study of ADL5859 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00603265
First received: January 17, 2008
Last updated: October 27, 2008
Last verified: August 2008
  Purpose

The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving the pain associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are thought to be due to damage to nerves caused by the diabetes. The study drug, ADL5859, has not been previously tested in diabetic patients; it is anticipated to provide pain relief in DPN because it demonstrated effectiveness in animal studies.


Condition Intervention Phase
Peripheral Neuropathy
Neuropathic Pain
Drug: ADL5859
Drug: duloxetine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of ADL5859 100 mg BID in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in mean pain intensity score (NPRS) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the mean NPRS proportion of subjects with 30% reduction in average pain score. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change in Sleep Interference Scale (SIS) from baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in the evening assessment of the 24-hour overall mean pain intensity score [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Change from baseline in NPRS at rest in the clinic [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Change from baseline in NPRS after walking 50 feet in the clinic [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: November 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADL5859 Drug: ADL5859
2 x 50 mg capsules twice daily for 28 days
Active Comparator: Duloxetine Drug: duloxetine
2 x 30 mg capsules once daily for 28 days
Other Name: Cymbalta
Sham Comparator: Placebo
lactose capsules
Drug: Placebo
Two capsules filled with lactose as a non-active comparator

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects between 18 and 75 years of age, inclusive
  • Body weight of at least 45 kg
  • Diabetes mellitus (type I or II) that is documented to be under stable glycemic control over a period of at least 3 months, as indicated by a HbgAIC of less than or equal to 12% and a stable dose of insulin or oral diabetic medication for 90 days prior to starting study medication
  • No change in diabetic medications is planned for the duration of the study
  • Evidence of symmetrical, bilateral pain in the lower extremities due to DPN
  • Presence of daily pain due to DPN for at least 3 months
  • Score greater than or equal to 3 on the physical examination portion of the MNSI
  • Average weekly pain score of greater than or equal to 4 on the NPRS for symmetrical neuropathic pain in the feet and legs
  • For male subjects, be surgically sterile or agree to use an appropriate method of contraception
  • For female subjects of childbearing potential, be surgically sterile or using an intrauterine device, or injectable, transdermal, or combination oral contraceptive deemed highly effective by the FDA
  • Be willing and able to comply with the protocol requirements
  • Be able to understand and willing to provide written informed consent in English

Exclusion Criteria:

  • Presence of pain conditions that cannot be distinguished from DPN
  • Presence of significant renal disease, as indicated by a serum creatinine greater than or equal to 2.0 mg/dL, or presence of significant hepatic disease
  • Have a history of a seizure disorder
  • Presence of serious or unstable cardiovascular disease, respiratory disease, hematologic illness, or a psychiatric condition
  • History of evidence of symptomatic orthostatic hypotension
  • History of a major depressive disorder, generalized anxiety disorder, eating disorder, or substance abuse (including alcohol) within the past year
  • History or evidence of mania, bipolar disorder, or psychosis
  • History of allergy to acetaminophen or duloxetine
  • Score of greater than or equal to 18 on the BDI-II or score of greater than zero on item 9 of the BDI-II
  • Use of any of the following concomitant medications: fluvoxamine; quinolone antimicrobials (ciprofloxacin and enoxacin); SSRIs; SNRIs; tricyclic antidepressants; opioids; NSAIDS; anticonvulsants; aspirin (with the exception of low-dose aspirin as cardiovascular prophylaxis); or CYP3A and P-glycoprotein transporter inhibitors
  • Pregnant, lactating, or plans to become pregnant during the study
  • Presence of foot or toe amputation
  • Participation in another study with an investigational compound within the previous 30 days prior to study medication administration, or concurrent participation in another clinical 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: NCT00603265

  Hide Study Locations
Locations
United States, California
Integrated Research Group
Riverside, California, United States, 92506
Torrance Clinical Research
Torrance, California, United States, 90505
United States, Florida
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Innovative Research of West Florida, Inc.
Largo, Florida, United States, 33770
Panhandle Family Care Associates & Emerald Coast Research Grp, Inc.
Marianna, Florida, United States, 32446
Renstar Medical Research
Ocala, Florida, United States, 34471
Radiant Research-St.Petersburg
Pinellas Park, Florida, United States, 33781
Doctor's Research Network
South Miami, Florida, United States, 33143
Laszlo J. Mate, MD
West Palm Beach, Florida, United States, 33407
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
United States, Kentucky
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Beacon Clinical Research
Brockton, Massachusetts, United States, 02301
United States, Missouri
Healthcare Research
Florissant, Missouri, United States, 63031
United States, Nebraska
Creighton Diabetes Center, Creighton Univ. Sch. of Medicine
Omaha, Nebraska, United States, 68131
United States, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, North Carolina
Clnical Study Center of Asheville
Asheville, North Carolina, United States, 28801
United States, Ohio
Radiant Research-Akron
Mogadore, Ohio, United States, 44260
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
Aquilo Research
Yukon, Oklahoma, United States, 73099
United States, Oregon
Clinical Research Consultants, Research Department
Medford, Oregon, United States, 97504
United States, Pennsylvania
Advanced Regional Center for Clinical Research (Ankle & Foot Care)
Altoona, Pennsylvania, United States, 16602
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Nerve & Muscle Center of Texas
Houston, Texas, United States, 77030
Invisions Consultants LLC
San Antonio, Texas, United States, 78217
Diabetes & Glandular Disease Research Associates
San Antonio, Texas, United States, 78229
S.A.M. Clinical Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23451
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Bruce Berger, MD Cubist Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Bruce Berger, MD, Adolor Corporation
ClinicalTrials.gov Identifier: NCT00603265     History of Changes
Other Study ID Numbers: 33CL231
Study First Received: January 17, 2008
Last Updated: October 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
Diabetic Peripheral Neuropathy
Neuropathic Pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuralgia
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on October 16, 2014