Safety and Efficacy Study of ADL5859 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
This study has been completed.
Sponsor:
Cubist Pharmaceuticals
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00603265
First received: January 17, 2008
Last updated: October 27, 2008
Last verified: August 2008
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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:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603265
Show 27 Study Locations
Show 27 Study LocationsSponsors 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:
|
Neuralgia Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Diabetic Neuropathies Pain Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Poisoning Substance-Related Disorders Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013