An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

NCT ID: NCT00385671

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-11-30

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.

Conditions

Diabetic Neuropathy, Painful

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pregabalin

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.

Group Type: ACTIVE_COMPARATOR

pregabalin

Intervention Type: DRUG

Pregabalin (PGB) orally (PO)

Duloxetine

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

Group Type: EXPERIMENTAL

duloxetine hydrochloride

Intervention Type: DRUG

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

Gabapentin + Duloxetine

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.

Group Type: EXPERIMENTAL

duloxetine hydrochloride

Intervention Type: DRUG

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

gabapentin

Intervention Type: DRUG

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

Interventions

duloxetine hydrochloride

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

Intervention Type: DRUG

pregabalin

Pregabalin (PGB) orally (PO)

Intervention Type: DRUG

gabapentin

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

Intervention Type: DRUG

Other Intervention Names

LY248686; Cymbalta

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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, United States

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, United States

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, United States

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, United States

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, United States

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, , Germany

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, , Germany

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, , Germany

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, , Germany

Countries

United States; Germany

References

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.

Reference Type: RESULT

PMID: 21719618 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24837444 (View on PubMed)

Other Identifiers

F1J-US-HMEZ

Identifier Type: OTHER

Identifier Source: secondary_id

10822

Identifier Type: -

Identifier Source: org_study_id