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

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

February 16, 2009

Start Date ^ICMJE

December 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in weekly average pain score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00625833 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in weekly average sleep interference scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Modified Brief Pain Inventory-Short Form [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Neuropathies

Intervention ^ICMJE

Drug: Placebo
Drug: [S,S]-Reboxetine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

330

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Czech Republic, Finland, Netherlands, South Africa, Spain

Administrative Information

NCT ID ^ICMJE

NCT00625833

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A6061037

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP