Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT ID: NCT01496365
Last Updated: 2021-01-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
452 participants
INTERVENTIONAL
2011-11-28
2012-09-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain
NCT02318706
Study to Evaluate the Efficacy and Safety of DS-1971a for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
NCT02673866
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
NCT04094662
A Study in Painful Diabetic Neuropathy
NCT01089556
Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)
NCT01564459
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DS-5565 5mg nighttime
DS-5565 5 mg/day (one 5 mg tablet at bedtime)
DS-5565 tablet
5mg and 10mg tablets
placebo capsule
DS-5565 10 mg at bedtime
DS-5565 10 mg/day (one 10 mg tablet at bedtime)
DS-5565 tablet
5mg and 10mg tablets
placebo capsule
DS-5565 15 mg at bedtime
DS-5565 15 mg/day (one 5 mg tablet plus one 10 mg tablet at bedtime)
DS-5565 tablet
5mg and 10mg tablets
placebo capsule
DS-5565 20 mg total per day
DS-5565 20 mg/day (one 10 mg tablet in the morning and one 10 mg tablet at bedtime)
DS-5565 tablet
5mg and 10mg tablets
placebo capsule
DS-5565 30 mg total per day
DS-5565 30 mg/day (one 5 mg tablet plus one 10 mg tablet in the morning and one 5 mg tablet plus one 10 mg tablet at bedtime)
DS-5565 tablet
5mg and 10mg tablets
placebo capsule
Pregabalin 300 mg total per day
Pregabalin 300 mg/day (two 150 mg capsules, in the morning and at bedtime)
pregabalin capsule
75mg and 150mg over-encapsulated
Placebo tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DS-5565 tablet
5mg and 10mg tablets
pregabalin capsule
75mg and 150mg over-encapsulated
Placebo tablet
placebo capsule
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
3. Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable)
4. Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles
5. At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS
6. At Randomization, a pain score of ≥ 40 mm on the SF-MPQ VAS and an ADPS of ≥ 4 on the 11-point NRS, the latter calculated from a minimum of 4 pain ratings in daily diaries obtained during the 1-week Baseline Period (prior to randomization)
7. Creatinine clearance \> 60 mL/min (estimated using the Cockcroft-Gault equation)
8. Antidiabetic and other medications anticipated to remain stable and constant during the study period
9. Women of child bearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol to avoid pregnancy during the study and for 4 weeks after study completion
Exclusion Criteria
2. Use of concomitant medications that may confound assessments of efficacy and/or safety (see Section 5.2)
3. Major psychiatric disorders
4. Have had a malignancy other than basal cell carcinoma within the past 2 years
5. At Visit 1, have a white blood cell count \< 2500/mm3, neutrophil count \< 1500/mm3, or platelet count \< 100 x 103/mm3
6. Clinically significant unstable diabetes mellitus, unstable hepatic, respiratory, or hematologic illness, unstable cardiovascular disease (including myocardial infarction in the 3 months prior to Visit 1), or symptomatic peripheral vascular disease
7. Clinically significant findings on the Screening ECG
8. History of pernicious anemia, untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or human immunodeficiency virus infection
9. Amputations of body parts other than toes
10. Prior therapeutic failure of pregabalin or gabapentin (considered unresponsive or intolerant to treatment); therapeutic failure implies lack of efficacy following full titration to effective doses (eg, 300 mg/day for pregabalin)
11. Known hypersensitivity to pregabalin or gabapentin
12. Requirement for concomitant anticonvulsant and antidepressant therapy, with the exception of stable doses of SSRIs
13. Neurologic disorders unrelated to DPN that may confound the assessment of pain associated with DPN
14. Skin conditions that could alter sensation
15. Other sources of pain that may confound assessment or self-evaluation of the pain due to DPN
16. Abuse of prescription medications, street drugs or alcohol (including alcohol dependence) within the last 1 year
17. Current enrollment in another investigational study, participation in another investigational study with the past 30 days, or other current or recent use of any investigational drug
18. Pregnancy (as based on lab test results) or breast feeding
19. Laboratory values exceeding limits listed in Table 4.1 of the protocol
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Domenico Merante, MD
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Buena Park, California, United States
Burbank, California, United States
Chino, California, United States
Fresno, California, United States
Huntington Beach, California, United States
Lakewood, California, United States
Lomita, California, United States
Long Beach, California, United States
Santa Monica, California, United States
Walnut Creek, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Golden, Colorado, United States
Cromwell, Connecticut, United States
Fairfield, Connecticut, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Hallandale, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Sunrise, Florida, United States
Columbus, Georgia, United States
Gainesville, Georgia, United States
Marietta, Georgia, United States
Evansville, Indiana, United States
Madisonville, Kentucky, United States
Paducah, Kentucky, United States
Hyattsville, Maryland, United States
Brockton, Massachusetts, United States
Farmington Hills, Michigan, United States
Olive Branch, Mississippi, United States
Florissant, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Duncansville, Pennsylvania, United States
Greensburg, Pennsylvania, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Chattanooga, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Norfolk, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Renton, Washington, United States
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DS5565-A-U201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.