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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00625833

Purpose

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.

Condition	Intervention	Phase
Diabetic Neuropathies	Drug: Placebo Drug: [S,S]-Reboxetine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems Peripheral Nerve Disorders

Drug Information available for: Reboxetine Reboxetine mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	330
Study Start Date:	December 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Oral tablet once a day dosing for 10 weeks.
2: Experimental	Drug: [S,S]-Reboxetine Oral tablet once a day dosing for 10 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625833

Hide Study Locations

Locations

United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
Pfizer Investigational Site
Birmingham, Alabama, United States, 35235
United States, California
Pfizer Investigational Site
Mission Viejo, California, United States, 92691
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80209
United States, Connecticut
Pfizer Investigational Site
New Britain, Connecticut, United States, 06050
Pfizer Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33609
Pfizer Investigational Site
Winter Haven, Florida, United States, 33880
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
Pfizer Investigational Site
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Pfizer Investigational Site
N. Dartmouth, Massachusetts, United States, 02747
United States, Mississippi
Pfizer Investigational Site
Tupelo, Mississippi, United States, 38801
Pfizer Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
Pfizer Investigational Site
Marionville, Missouri, United States, 65705
Pfizer Investigational Site
Springfield, Missouri, United States, 65807
United States, New Jersey
Pfizer Investigational Site
Hamilton, New Jersey, United States, 08690
Pfizer Investigational Site
Hamilton, New Jersey, United States, 08690
Pfizer Investigational Site
Elizabeth, New Jersey, United States, 07207
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10024
Pfizer Investigational Site
Buffalo, New York, United States, 14209
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Rhode Island
Pfizer Investigational Site
Cranston, Rhode Island, United States, 02920
Pfizer Investigational Site
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
Pfizer Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Pfizer Investigational Site
Bartlett, Tennessee, United States, 38133
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Dallas, Texas, United States, 75390-8858
Pfizer Investigational Site
Houstan, Texas, United States, 77079
Pfizer Investigational Site
Houston, Texas, United States, 77081
Pfizer Investigational Site
Beaumont, Texas, United States, 77701
Pfizer Investigational Site
Beaumont, Texas, United States, 77706
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Czech Republic
Pfizer Investigational Site
Ceske Budejovice, Czech Republic, 370 87
Pfizer Investigational Site
Brno, Czech Republic, 636 00
Pfizer Investigational Site
Ostrava, Czech Republic, 702 00
Czech Republic, 760 01
Pfizer Investigational Site
Zlin, 760 01, Czech Republic
Finland
Pfizer Investigational Site
Lahti, Finland, 15110
Pfizer Investigational Site
Helsinki, Finland, 00290
Pfizer Investigational Site
Kokkola, Finland, 67100
Pfizer Investigational Site
Lohja, Finland, 08200
Netherlands
Pfizer Investigational Site
Almere, Netherlands, 1311 RL
Pfizer Investigational Site
Amsterdam, Netherlands, 1105 AZ
Pfizer Investigational Site
Venlo, Netherlands, 5912 BL
South Africa
Pfizer Investigational Site
Cape Town, South Africa, 7130
South Africa, Cape Town
Pfizer Investigational Site
Worcester, Cape Town, South Africa, 6850
South Africa, Free State
Pfizer Investigational Site
Bloemfontein, Free State, South Africa, 9301
South Africa, Gauteng
Pfizer Investigational Site
Ennerdale, Gauteng, South Africa, 1820
Pfizer Investigational Site
Tshwane, Gauteng, South Africa, 0204
South Africa, Kwa- Zulu Natal
Pfizer Investigational Site
Stanger, Kwa- Zulu Natal, South Africa, 4450
South Africa, KwaZulu Natal
Pfizer Investigational Site
Durban, KwaZulu Natal, South Africa, 4000
Spain
Pfizer Investigational Site
BARCELONA, Spain, 08035
Pfizer Investigational Site
MADRID, Spain, 28040
Pfizer Investigational Site
PONTEVEDRA, Spain, 36071
Pfizer Investigational Site
VALENCIA, Spain, 46014
Spain, BARCELONA
Pfizer Investigational Site
L'HOSPITALET DE LLOBREGAT, BARCELONA, Spain, 08907
Spain, LA CORUÑA
Pfizer Investigational Site
SANTIAGO DE COMPOSTELA, LA CORUÑA, Spain, 15706

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061037
Study First Received:	February 14, 2008
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00625833 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Diabetic Neuropathies
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Diabetes Mellitus
Psychotropic Drugs

Endocrine System Diseases
Pharmacologic Actions
Neuromuscular Diseases
Peripheral Nervous System Diseases
Therapeutic Uses
Central Nervous System Agents
Diabetes Complications
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on November 20, 2009