We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

[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.)
ClinicalTrials.gov Identifier:
First Posted: July 6, 2006
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • Physical examination [ Time Frame: duration of study ]
  • 12-lead ECG [ Time Frame: duration of study ]
  • Hematology/Biochemistry [ Time Frame: duration of study ]
  • Adverse events [ Time Frame: duration of study ]

Secondary Outcome Measures:
  • Pain Visual Analogue Scale [ Time Frame: duration of study ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: duration of study ]
  • Modified Brief Pain Inventory-Short Form [ Time Frame: duration of study ]
  • Patient Global Impression of Change [ Time Frame: duration of study ]
  • SF-12 Health Survey [ Time Frame: duration of study ]
  • EQ-5D [ Time Frame: duration of study ]
  • Analgesic Treatment Satisfaction Scale [ Time Frame: duration of study ]
  • Pain-related Medication Utilization [ Time Frame: duration of study ]

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
Drug: [S,S]-Reboxetine
Standard Care
Standard Care
Drug: Any
Any standard of care treatment for DPN


Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348894

  Show 94 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00348894     History of Changes
Other Study ID Numbers: A6061031
First Submitted: July 4, 2006
First Posted: July 6, 2006
Last Update Posted: June 1, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs