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[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
History of Changes

July 4, 2006
May 31, 2011
July 2006
October 2007   (final data collection date for primary outcome measure)
  • 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 ]
Vital signs, Physical examination, 12-lead ECG, Hematology/Biochemistry, Adverse events
Complete list of historical versions of study NCT00348894 on ClinicalTrials.gov Archive Site
  • 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 ]
Pain Visual Analogue Scale 	 Patient Global Impression of Change Neuropathic Pain Symptom Inventory Modified Brief Pain Inventory-Short Form SF-12 Health Survey EQ-5D Analgesic Treatment Satisfaction Scale Pain-related Medication Utilization
Not Provided
Not Provided
 
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
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).

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Drug: [S,S]-Reboxetine
    [S,S]-reboxetine
  • Drug: Any
    Any standard of care treatment for DPN
  • Experimental: Open Treatment
    [S,S]-reboxetine
    Intervention: Drug: [S,S]-Reboxetine
  • Standard Care
    Standard Care
    Intervention: Drug: Any
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Croatia,   Estonia,   Finland,   Germany,   India,   Poland,   Russian Federation,   South Africa,   Sweden,   Ukraine,   United Kingdom
 
NCT00348894
A6061031
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP