A Study in Patients With Diabetic Peripheral Neuropathic Pain in China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01179672
First received: August 10, 2010
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

The purpose of this trial is to assess the efficacy of duloxetine 60mg (once daily, QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the patient's diary in patients with diabetic peripheral neuropathic pain.


Condition Intervention Phase
Diabetic Neuropathy, Painful
Drug: Duloxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China: Duloxetine Versus Placebo

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean change from baseline to 12 week endpoint in the pain severity score [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline to 12 week endpoint in night pain and worst pain [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12 week endpoint in the Brief Pain Inventory (BPI)-Severity scale [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12 week endpoint in the Clinical Global Impression of Severity (CGI-S) scale [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Improvement (PGI-I) scale at 12 week endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12 week endpoint in the Sensory portion of the Short-form McGill pain questionnaire [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who experience equal or greater than 30%, 50% or 75% reduction from baseline to 12 week endpoint in average daily pain [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who experience equal or greater than 30%, 50% or 75% reduction from baseline to 12 week endpoint in BPI-Severity average pain scores [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12 week endpoint in the Brief Pain Inventory (BPI) Interference scores [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to 12 week endpoint in the Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine Drug: Duloxetine
30 mg administered orally, once daily for first 1 week; 60 mg administered orally, once daily for remaining 11 weeks; 30 mg administered orally, once daily for 1 week during taper period
Other Names:
  • Cymbalta
  • LY#248686
Placebo Comparator: Placebo Drug: Placebo
Administered orally, once daily for 12 weeks; administered orally, once daily for 1 week during taper period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present with pain due to bilateral peripheral neuropathy

    • Patients must have pain caused by Type 1 or Type 2 diabetes mellitus
    • Pain must begin in the feet with relatively symmetrical onset
    • Daily pain should be present for at least 6 months
    • Diagnosis must be confirmed by a score of at least 3 on the Michigan Neuropathy Screening Inventory
  • Females must test negative for a serum pregnancy test at Screening. Females of child-bearing potential (who are not surgically sterilized and between menarche and 1 year postmenopause) must agree to use a medically acceptable and reliable means of birth control, during the study and for 1 month following the last study dose.
  • Stable glycemic control as assessed by a physician investigator and a glycosylated hemoglobin (HbA1c) <12% before randomization
  • Score of greater than or equal to 4 on the Brief Pain Inventory 24-hour average pain item at Screening.
  • Full completion of the daily diaries for at least 80% of the days between the second and third time you come to the hospital (Screening).

Exclusion Criteria:

  • Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Current (less than or equal to 1 year) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I diagnosis of major depressive disorder, dysthymia, anxiety disorders (excluding phobias), alcohol or eating disorders as determined by the Mini-International Neuropsychiatric Interview or a previous diagnosis
  • DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by patient history or by diagnosis using specific Michigan Neuropathy Screening Instrument modules
  • Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychological conditions that in the opinion of investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
  • At Screening ALT greater than 2 times upper limit of normal, based on central laboratory reference ranges times upper limit of normal, based on central laboratory reference ranges
  • Prior renal transplant, current renal dialysis, or serum creatinine laboratory value >1.5 times upper limit of normal, based on central laboratory reference ranges at Screening.
  • Historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy
  • Pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the diabetic neuropathy pain. Examples of painful conditions that could be confused with diabetic neuropathy pain include peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, skin condition in the area of the neuropathy that could alter sensation, other painful conditions
  • Patients who have previously completed or withdrawn from this study or have been previously treated with duloxetine, including patients who participated in study F1J-MC-HMEQ, even those in the placebo arm
  • Patients taking excluded medications that cannot be stopped at Screening
  • Treatment with a Monoamine oxidase inhibitor or fluoxetine within 30 days of the third Screening
  • Patients with a positive Hepatitis B surface antigen and/or Hepatitis C antibody are to be excluded if they have any of the following:

    • Hepatic dysfunction as determined by the investigator or
    • Clinical manifestations of liver disease within the previous year such as unexplained pruritus, unexplained dark urine, jaundice, unexplained right upper quadrant tenderness, unexplained "flu-like" symptoms or
    • AST, ALT, or bilirubin above the normal reference range.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179672

Locations
China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, China, 100730
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bengbu, China, 233004
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Changchun, China, 130021
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chengdu, China, 610072
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chongqing, China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guang Zhou, China, 510515
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jinan, China, 250001
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nanjin, China, 210006
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Qingdao, China, 266003
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shanghai, China, 200040
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shantou, China, 515041
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shi Jia Zhuang, China, 050051
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tianjin, China, 300211
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Xi'An, China, 710061
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yueyang, China, 414000
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01179672     History of Changes
Other Study ID Numbers: 13649, F1J-MC-HMGV
Study First Received: August 10, 2010
Last Updated: September 24, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Diabetic Peripheral Neuropathic Pain

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
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
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014