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NCT00625833 Clinical Trial

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

Diabetic Neuropathies Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00625833
Other study ID # A6061037
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 2007
Est. completion date November 2008

Study information
Verified date December 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 330
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Oral tablet once a day dosing for 10 weeks.
• [S,S]-Reboxetine
Oral tablet once a day dosing for 10 weeks.

Locations
Country Name City State
Czechia Pfizer Investigational Site Brno
Czechia Pfizer Investigational Site Ceske Budejovice
Czechia Pfizer Investigational Site Ostrava
Czechia Pfizer Investigational Site Zlin
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Kokkola
Finland Pfizer Investigational Site Lahti
Finland Pfizer Investigational Site Lohja
Netherlands Pfizer Investigational Site Almere
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Venlo
South Africa Pfizer Investigational Site Bloemfontein Free State
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Durban KwaZulu Natal
South Africa Pfizer Investigational Site Ennerdale Gauteng
South Africa Pfizer Investigational Site Stanger Kwa- Zulu Natal
South Africa Pfizer Investigational Site Tshwane Gauteng
South Africa Pfizer Investigational Site Worcester Cape Town
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site L'hospitalet de Llobregat Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Pontevedra
Spain Pfizer Investigational Site Santiago de Compostela LA Coruña
Spain Pfizer Investigational Site Valencia
United States Pfizer Investigational Site Anniston Alabama
United States Pfizer Investigational Site Bartlett Tennessee
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Cranston Rhode Island
United States Pfizer Investigational Site Cumberland Rhode Island
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Elizabeth New Jersey
United States Pfizer Investigational Site Hamilton New Jersey
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Marionville Missouri
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Mission Viejo California
United States Pfizer Investigational Site Myrtle Beach South Carolina
United States Pfizer Investigational Site New Britain Connecticut
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site North Dartmouth Massachusetts
United States Pfizer Investigational Site Springfield Missouri
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tupelo Mississippi
United States Pfizer Investigational Site Waterbury Connecticut
United States Pfizer Investigational Site Winter Haven Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in weekly average pain score 8 weeks
Secondary 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
Secondary Change from baseline in weekly average sleep interference scale 8 weeks
Secondary Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory 8 weeks
Secondary Modified Brief Pain Inventory-Short Form 8 weeks
See also
  Status Clinical Trial Phase
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Withdrawn NCT04106050 - Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy Phase 1
Completed NCT04088929 - The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy Phase 2
Completed NCT01939366 - Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves Phase 2
Withdrawn NCT00815932 - The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy N/A
Completed NCT01926522 - Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients N/A
Not yet recruiting NCT01180608 - Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain N/A
Completed NCT00760955 - Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Completed NCT00380913 - Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy Phase 4
Terminated NCT00756041 - Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy Phase 2
Completed NCT05255497 - The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy N/A
Completed NCT06061237 - Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy N/A
Terminated NCT02915263 - The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes Phase 2
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT06373809 - Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy Early Phase 1
Completed NCT05968131 - Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy N/A
Completed NCT00282685 - Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy Phase 1
Completed NCT00135109 - Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy Phase 3
Completed NCT06292962 - Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain N/A
Completed NCT05058807 - Effects of Whole Body Vibration in Diabetic Peripheral Neuropathy . N/A

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