Safety and Efficacy Study of ADL5859 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy - Full Text View

Sponsored by:	Adolor Corporation
Information provided by:	Adolor Corporation
ClinicalTrials.gov Identifier:	NCT00603265

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 II

MedlinePlus related topics: Diabetes Peripheral Nerve Disorders

Drug Information available for: Lactose Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Adolor Corporation:

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
ADL5859: Experimental	Drug: ADL5859 2 x 50 mg capsules twice daily for 28 days
Duloxetine: Active Comparator	Drug: duloxetine 2 x 30 mg capsules once daily for 28 days
Placebo: Sham Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603265

Show 27 Study Locations

Sponsors and Collaborators

Adolor Corporation

Investigators

Study Director:

Bruce Berger, MD

Adolor Corporation

More Information

Adolor Corporation home web page address This link exits the ClinicalTrials.gov site

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

Keywords provided by Adolor Corporation:

Diabetic Peripheral Neuropathy
Neuropathic Pain

Study placed in the following topic categories:

Dopamine
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases

Pain
Endocrinopathy
Serotonin
Duloxetine
Diabetes Complications

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Nervous System Diseases
Physiological Effects of Drugs

Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009