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Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00603265•Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Participants were permitted to take acetaminophen 650 to 975 mg every 4 to 6 hours (up to a total of 4 grams in 24 hours) as needed for pain relief.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants between 18 and 75 years of age, inclusive
•Body weight of at least 45 kilograms (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 glycosylated hemoglobin (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 diabetic peripheral neuropathy (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 Michigan Neuropathy Screening Instrument (MNSI)
•Average weekly pain score of greater than or equal to 4 on the numeric pain rating scale (NPRS) for symmetrical neuropathic pain in the feet and legs
•For male participants, be surgically sterile or agree to use an appropriate method of contraception
•For female participants of childbearing potential, be surgically sterile or using an intrauterine device, or injectable, transdermal, or combination oral contraceptive deemed highly effective by the Food and Drug Administration (FDA)
+2 more criteria

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 milligrams per deciliter (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 Beck Depression Inventory II (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); selective serotonin reuptake inhibitors (SSRIs); serotonin norepinephrine reuptake inhibitors (SNRIs); tricyclic antidepressants; opioids; nonsteroidal anti-inflammatory drugs (NSAIDS); anticonvulsants; aspirin (with the exception of low-dose aspirin as cardiovascular prophylaxis); or cytochrome P4503A (CYP3A) and P-glycoprotein transporter inhibitors
+3 more criteria

Locations (27)

Integrated Research Group

Riverside, California, United States

Torrance Clinical Research

Torrance, California, United States

FPA Clinical Research

Kissimmee, Florida, United States

Innovative Research of West Florida, Inc.

Largo, Florida, United States

Panhandle Family Care Associates & Emerald Coast Research Grp, Inc.

Marianna, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Radiant Research-St.Petersburg

Pinellas Park, Florida, United States

Doctor's Research Network

South Miami, Florida, United States

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Laszlo J. Mate, MD

West Palm Beach, Florida, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

July 1, 2015

Enrollment

226

ACTUAL participants

Conditions

Peripheral NeuropathyNeuropathic Pain

Interventions

ADL5859

DRUG

Duloxetine

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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