[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

This study has been terminated.
(- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00348894
First received: July 4, 2006
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy


Condition Intervention Phase
Pain
Drug: [S,S]-Reboxetine
Drug: Any
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Vital signs [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • 12-lead ECG [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Hematology/Biochemistry [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain Visual Analogue Scale [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory-Short Form [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • SF-12 Health Survey [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Analgesic Treatment Satisfaction Scale [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Pain-related Medication Utilization [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Treatment
[S,S]-reboxetine
Drug: [S,S]-Reboxetine
[S,S]-reboxetine
Standard Care
Standard Care
Drug: Any
Any standard of care treatment for DPN

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
  • Patients at screening must have a score >/=40 mm on the pain visual analogue scale

Exclusion Criteria:

  • Patients with significant hepatic impairment
  • Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
  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: NCT00348894

  Show 94 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: NCT00348894     History of Changes
Other Study ID Numbers: A6061031
Study First Received: July 4, 2006
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
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 October 19, 2014