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

This study has been terminated.
(Study was terminated for futility following the planned interim analysis.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00625833
First received: February 14, 2008
Last updated: February 16, 2009
Last verified: February 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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 Comparator: Placebo Drug: Placebo
Oral tablet once a day dosing for 10 weeks.
Experimental: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 56 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014