Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients

Completed

• Conditions: Pain
• Interventions: Drug: Cymbalta

• Registration Number: NCT02215798
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Primary objective: To estimate the frequency of adverse events, serious and non-serious in Filipino patients with diabetic peripheral neuropathic pain treated with duloxetine 60mg once daily within the study duration of approximately 6-8 weeks in a naturalistic clinical setting. Secondary objective: To evaluate the change from baseline to endpoint in the Brief Pain Inventory (BPI) and Neuropathic Pain Questionnaire (NPQ) assessed by the investigators in duloxetine use in the treatment of diabetic peripheral neuropathic pain among Filipino patients within the study duration of approximately 6-8 weeks in a naturalistic clinical setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-10
• Status Verified: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cymbalta	Cymbalta	-

Primary Outcome Measures

Name	Time	Method
Frequency of serious and non-serious adverse events	up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Brief Pain Inventory (BPI)	up to 8 weeks
Change from baseline in Neuropathic Pain Questionnaire (NPQ)	up to 8 weeks