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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00348894

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Reboxetine Reboxetine mesylate

U.S. FDA Resources

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 ]

Estimated Enrollment:	800
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Treatment: Experimental [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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061031
Study First Received:	July 4, 2006
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00348894 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Diabetic Neuropathies
Adrenergic Agents
Diabetes Mellitus
Psychotropic Drugs
Endocrine System Diseases
Pain

Neuromuscular Diseases
Peripheral Nervous System Diseases
Endocrinopathy
Diabetes Complications
Antidepressive Agents
Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Diabetic Neuropathies
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Diabetes Mellitus
Psychotropic Drugs

Endocrine System Diseases
Pharmacologic Actions
Neuromuscular Diseases
Peripheral Nervous System Diseases
Therapeutic Uses
Central Nervous System Agents
Diabetes Complications
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on September 11, 2009