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

NCT00625833 | Terminated Phase 2

• 1 other identifier: A6061037
• Study Type: interventional
• Target: 330
• Locations: 6 countries
• Sites: 56

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.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

• Change from baseline in weekly average pain score

  8 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Drug: [S,S]-Reboxetine

Interventions

Placebo DRUG

Oral tablet once a day dosing for 10 weeks.

Placebo

[S,S]-Reboxetine DRUG

Oral tablet once a day dosing for 10 weeks.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (56)

Pfizer Investigational Site

Anniston, Alabama, 36207, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35235, United States

Location

Pfizer Investigational Site

Mission Viejo, California, 92691, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80209, United States

Location

Pfizer Investigational Site

New Britain, Connecticut, 06050, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33609, United States

Location

Pfizer Investigational Site

Winter Haven, Florida, 33880, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40503, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40213, United States

Location

Pfizer Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

Pfizer Investigational Site

Jackson, Mississippi, 39202, United States

Location

Pfizer Investigational Site

Tupelo, Mississippi, 38801, United States

Location

Pfizer Investigational Site

Marionville, Missouri, 65705, United States

Location

Pfizer Investigational Site

Springfield, Missouri, 65807, United States

Location

Pfizer Investigational Site

Elizabeth, New Jersey, 07207, United States

Location

Pfizer Investigational Site

Hamilton, New Jersey, 08690, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14209, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

New York, New York, 10024, United States

Location

Pfizer Investigational Site

Cranston, Rhode Island, 02920, United States

Location

Pfizer Investigational Site

Cumberland, Rhode Island, 02864, United States

Location

Pfizer Investigational Site

Myrtle Beach, South Carolina, 29572, United States

Location

Pfizer Investigational Site

Bartlett, Tennessee, 38133, United States

Location

Pfizer Investigational Site

Beaumont, Texas, 77701, United States

Location

Pfizer Investigational Site

Beaumont, Texas, 77706, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-8858, United States

Location

Pfizer Investigational Site

Houston, Texas, 77079, United States

Location

Pfizer Investigational Site

Houston, Texas, 77081, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

Pfizer Investigational Site

Brno, 636 00, Czechia

Location

Pfizer Investigational Site

České Budějovice, 370 87, Czechia

Location

Pfizer Investigational Site

Ostrava, 702 00, Czechia

Location

Pfizer Investigational Site

Zlín, 760 01, Czechia

Location

Pfizer Investigational Site

Helsinki, 00290, Finland

Location

Pfizer Investigational Site

Kokkola, 67100, Finland

Location

Pfizer Investigational Site

Lahti, 15110, Finland

Location

Pfizer Investigational Site

Lohja, 08200, Finland

Location

Pfizer Investigational Site

Almere Stad, 1311 RL, Netherlands

Location

Pfizer Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

Pfizer Investigational Site

Venlo, 5912 BL, Netherlands

Location

Pfizer Investigational Site

Worcester, Cape Town, 6850, South Africa

Location

Pfizer Investigational Site

Bloemfontein, Free State, 9301, South Africa

Location

Pfizer Investigational Site

Ennerdale, Gauteng, 1820, South Africa

Location

Pfizer Investigational Site

Pretoria, Gauteng, 0204, South Africa

Location

Pfizer Investigational Site

Durban, KwaZulu-Natal, 4000, South Africa

Location

Pfizer Investigational Site

KwaDukuza, KwaZulu-Natal, 4450, South Africa

Location

Pfizer Investigational Site

Cape Town, 7130, South Africa

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Pfizer Investigational Site

Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Madrid, 28040, Spain

Location

Pfizer Investigational Site

Pontevedra, 36071, Spain

Location

Pfizer Investigational Site

Valencia, 46014, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

O-methyl reboxetine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 28, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

US (32); NL (3); ZA (7); FI (4); ES (6); CZ (4)