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Trial record 1 of 1 for:    NCT00348894
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[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

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. Identifier: NCT00348894
Recruitment Status : Terminated (- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.)
First Posted : July 6, 2006
Last Update Posted : June 1, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: [S,S]-Reboxetine Drug: Any Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
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).
Study Start Date : July 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Open Treatment
Drug: [S,S]-Reboxetine

Standard Care
Standard Care
Drug: Any
Any standard of care treatment for DPN

Primary Outcome Measures :
  1. Vital signs [ Time Frame: duration of study ]
  2. Physical examination [ Time Frame: duration of study ]
  3. 12-lead ECG [ Time Frame: duration of study ]
  4. Hematology/Biochemistry [ Time Frame: duration of study ]
  5. Adverse events [ Time Frame: duration of study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00348894

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00348894    
Other Study ID Numbers: A6061031
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous 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