NCT00385671

Brief Summary

To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
407

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
2 countries

9 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

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 18, 2010

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

2.9 years

First QC Date

October 6, 2006

Results QC Date

August 23, 2010

Last Update Submit

July 22, 2011

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine

    This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.

    baseline, 12 weeks

Secondary Outcomes (50)

  • Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin

    baseline, 12 weeks

  • Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity

    baseline, 12 weeks

  • Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score

    baseline, 12 weeks

  • Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)

    baseline, 12 weeks

  • Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks

    12 weeks

  • +45 more secondary outcomes

Study Arms (3)

Pregabalin

ACTIVE COMPARATOR

Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \& Germany) or 150 mg BID (Canada), PO for 10 weeks.

Drug: pregabalin

Duloxetine

EXPERIMENTAL

Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.

Drug: duloxetine hydrochloride

Gabapentin + Duloxetine

EXPERIMENTAL

Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.

Drug: duloxetine hydrochlorideDrug: gabapentin

Interventions

duloxetine hydrochlorideDRUG

Duloxetine (DLX) once daily (QD), orally (PO)

Also known as: LY248686, Cymbalta
DuloxetineGabapentin + Duloxetine
pregabalinDRUG

Pregabalin (PGB) orally (PO)

Pregabalin
gabapentinDRUG

Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)

Gabapentin + Duloxetine

Eligibility Criteria

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

You may qualify if:

  • You must have been diagnosed with Diabetic Neuropathic Pain
  • Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
  • Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
  • Patient must agree not to change dose of gabapentin between Visits 1 and 2
  • You must have stable glycemic control

You may not qualify if:

  • Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
  • Current diagnosis or history of hemangiosarcoma
  • Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
  • Patients with uncontrolled narrow-angle glaucoma
  • Presence of a current seizure disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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.

Torrance, California, 90503, United States

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.

Cromwell, Connecticut, 06416, United States

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.

Staten Island, New York, 10312, United States

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.

Greenville, North Carolina, 27834, United States

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.

Midvale, Utah, 84047, United States

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.

Bochum, D-44805, Germany

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.

Dresden, 01307, Germany

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.

Hamburg, 20354, Germany

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.

Siegen, 57072, Germany

Location

Related Publications (2)

  • Tanenberg RJ, Irving GA, Risser RC, Ahl J, Robinson MJ, Skljarevski V, Malcolm SK. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. Mayo Clin Proc. 2011 Jul;86(7):615-26. doi: 10.4065/mcp.2010.0681.

    PMID: 21719618RESULT

  • Irving G, Tanenberg RJ, Raskin J, Risser RC, Malcolm S. Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain. Int J Clin Pract. 2014 Sep;68(9):1130-40. doi: 10.1111/ijcp.12452. Epub 2014 May 18.

    PMID: 24837444DERIVED

Related Links

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Duloxetine HydrochloridePregabalinGabapentin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compoundsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsAmino AcidsAmino Acids, Peptides, and ProteinsAminesCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Results Point of Contact

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

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2006

First Posted

October 11, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Study Completion

November 1, 2009

Last Updated

July 26, 2011

Results First Posted

October 18, 2010

Record last verified: 2011-07

Locations

DE(4)US(5)