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Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00408993
First received: December 6, 2006
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.


Condition Intervention Phase
Diabetic Neuropathies
Drug: Duloxetine Hydrochloride
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).


Secondary Outcome Measures:
  • Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).

  • Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

  • Time Course of Change in Patient Global Impression - Improvement Scale [ Time Frame: baseline, over 12 weeks ] [ Designated as safety issue: No ]
    A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  • Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.

  • Number of Participants Discontinuing Due to Adverse Events [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]
    Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.

  • Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.

  • Vital Signs - Weight [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Change from baseline to endpoint in body weight.

  • Vital Signs - Pulse Rate [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Change from baseline to endpoint in pulse rate.

  • Vital Signs - Blood Pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Change from baseline to endpoint in systolic and diastolic blood pressure.

  • Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.

  • Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Significantly different laboratory values between the two groups in baseline to endpoint changes


Enrollment: 215
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
Drug: Duloxetine Hydrochloride
60 mg every day (QD) (morning or evening), by mouth (PO)
Other Names:
  • LY248686
  • Cymbalta
Placebo Comparator: Placebo
Placebo every day (QD), by mouth (PO) for 12 weeks
Drug: Placebo
Placebo every day (QD), by mouth (PO)

  Eligibility

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

Inclusion Criteria:

  • Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
  • May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
  • Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Exclusion Criteria:

  • Glycosylated hemoglobin (A1C) > 12%
  • Severe hepatic disease
  • History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  • Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
  • Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
  • Treatment of fluoxetine within 30 days of starting the study.
  • Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408993

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, 100101
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.
Changsha, China, 410011
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.
Harbin, China, 150086
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, 210012
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.
Nanjing, China, 210029
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, 200233
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.
Wu Han, China, 430022
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri from 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Publications:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00408993     History of Changes
Other Study ID Numbers: 10599, F1J-MC-HMEQ(a)
Study First Received: December 6, 2006
Results First Received: February 5, 2009
Last Updated: July 22, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014