A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00837941

Enrollment

Registered

2009-02-06

Start date

2009-04-30

Completion date

2009-09-30

Last updated

2015-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful Diabetic Neuropathy

Brief summary

The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.

Interventions

DRUGComparator: B: Duloxetine

1 Duloxetine hydrochloride 60 mg capsule

DRUGComparator: C: Diphenhydramine hydrochloride

1 Diphenhydramine hydrochloride 25mg capsule

DRUGComparator: A: Pregabalin

1 Pregabalin 300 mg capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin * Patient has pain in both feet that occurred after onset of diabetes * Patient agrees to maintain a consistent activity level throughout the study * Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy * Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study * Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study

Exclusion criteria

* Patient has a history of congestive heart failure * Patient has/had a seizure disorder * Patient has tried and failed 3 or more drugs to treat neuropathic pain * Patient is currently taking pregabalin or duloxetine hydrochloride * Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma) * Patient has history of hepatitis B or C or HIV infection * Patient has skin-condition that may decrease sensitivity in area of neuropathic pain

Design outcomes

Primary

Measure	Time frame
analgesic efficacy measured by patients self reported pain level after single dose administration	5-11 hours after single dose is administered

Secondary

Measure	Time frame
The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo	24 hours after single dose is administered

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026