A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00625833

Enrollment

330

Registered

2008-02-28

Start date

2007-12-31

Completion date

2008-11-30

Last updated

2019-12-13

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

Conditions

Diabetic Neuropathies

Brief summary

This is a trial to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of \[S,S\]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.

Interventions

DRUGPlacebo

Oral tablet once a day dosing for 10 weeks.

DRUG[S,S]-Reboxetine

Oral tablet once a day dosing for 10 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female of any race at least 18 years of age * Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year * Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale

Exclusion criteria

* Patients with significant hepatic impairment * Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain * Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy * Amputations other than toes * A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression * History of transient ischemic attack or stroke * Myocardial infarction or unstable angina within the past three months

Design outcomes

Primary

Measure	Time frame
Change from baseline in weekly average pain score	8 weeks

Secondary

Measure	Time frame
Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)	8 weeks
Change from baseline in weekly average sleep interference scale	8 weeks
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory	8 weeks
Modified Brief Pain Inventory-Short Form	8 weeks

Countries

Czechia, Finland, Netherlands, South Africa, Spain, United States

Outcome results

None listed

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