Who is sponsoring NCT00385671?

NCT00385671 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT00385671?

Interventions in NCT00385671: duloxetine hydrochloride, pregabalin, gabapentin.

What condition does NCT00385671 study?

NCT00385671 studies Diabetic Neuropathy, Painful.

Is NCT00385671 still recruiting?

NCT00385671 is currently completed. Last updated 22 July 2011.

Are results published for NCT00385671?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2011-07-22 · How we verify

NCT00385671

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain

Completed Phase 4 Results posted Last updated 22 July 2011

What this trial tests

Phase 4 trial testing duloxetine hydrochloride in Diabetic Neuropathy, Painful in 407 participants. Completed in 1 November 2009.

Timeline

1 September 2006

Primary endpoint
1 August 2009

1 November 2009

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	407
Start date	1 September 2006
Primary completion	1 August 2009
Estimated completion	1 November 2009
Sites	9 locations across United States, Germany

Drugs / interventions tested

duloxetine hydrochloride — full drug profile →
pregabalin (Pregabalin) — full drug profile →
gabapentin (Gabapentin) — full drug profile →

Conditions studied

Diabetic Neuropathy, Painful — all drugs for Diabetic Neuropathy, Painful →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Diabetic Neuropathy, Painful. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine
Time frame: baseline, 12 weeks
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.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia.
Lunn MP, Hughes RA, Wiffen PJ. · · 2014 · cited 259× · PMID 24385423 · DOI 10.1002/14651858.cd007115.pub3
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.
Tanenberg RJ, Irving GA, Risser RC, Ahl J, et al · · 2011 · cited 69× · PMID 21719618 · DOI 10.4065/mcp.2010.0681
Molecular mechanisms of pain in acute pancreatitis: recent basic research advances and therapeutic implications.
Wu Y, Han C, Luo R, Cai W, et al · · 2023 · cited 9× · PMID 38188196 · DOI 10.3389/fnmol.2023.1331438

Verify or expand the search:

Other trials of duloxetine hydrochloride

Trials testing the same drug.

NCT01598298 — S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy · Phase 3 · completed

Other recruiting trials for Diabetic Neuropathy, Painful

Currently open trials in the same condition.

NCT05623111 — Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities · Phase 2 · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00385671 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 22 July 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00385671.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing