NCT00408993

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 2, 2009

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

December 6, 2006

Results QC Date

February 5, 2009

Last Update Submit

July 22, 2011

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score

    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).

    Baseline and 12 weeks

Secondary Outcomes (12)

  • Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores

    Baseline and 12 weeks

  • Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity

    Baseline and 12 weeks

  • Time Course of Change in Patient Global Impression - Improvement Scale

    baseline, over 12 weeks

  • Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)

    Baseline and 12 weeks

  • Number of Participants Discontinuing Due to Adverse Events

    over 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Duloxetine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo every day (QD), by mouth (PO) for 12 weeks

Drug: Placebo

Interventions

Duloxetine HydrochlorideDRUG

60 mg every day (QD) (morning or evening), by mouth (PO)

Also known as: LY248686, Cymbalta
Duloxetine
PlaceboDRUG

Placebo every day (QD), by mouth (PO)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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, 100101, China

Location

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, 410011, China

Location

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, 150086, China

Location

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, 210012, China

Location

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, 210029, China

Location

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, 200233, China

Location

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.

Wuhan, 430022, China

Location

Related Publications (1)

  • Gao Y, Ning G, Jia WP, Zhou ZG, Xu ZR, Liu ZM, Liu C, Ma JH, Li Q, Cheng LL, Wen CY, Zhang SY, Zhang Q, Desaiah D, Skljarevski V. Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. Chin Med J (Engl). 2010 Nov;123(22):3184-92.

    PMID: 21163113RESULT

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
1-800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 8, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 26, 2011

Results First Posted

June 2, 2009

Record last verified: 2011-07

Locations

CN(7)