[S,S]-Reboxetine Long Term Safety Study In Chronic Painfu... | NCT00348894

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).

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Open Treatment	Experimental	[S,S]-reboxetine	Drug: [S,S]-Reboxetine
Standard Care	Other	Standard Care	Drug: Any

Name	Type	Description	Arm Group Labels	Other Names
[S,S]-Reboxetine	Drug	[S,S]-reboxetine	Open Treatment
Any

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vital signs		duration of study
Physical examination		duration of study
12-lead ECG		duration of study
Hematology/Biochemistry		duration of study
Adverse events		duration of study

Measure	Description	Time Frame
Pain Visual Analogue Scale		duration of study
Neuropathic Pain Symptom Inventory		duration of study
Modified Brief Pain Inventory-Short Form

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35233	United States
Pfizer Investigational Site

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms