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

NCT ID: NCT02215798

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 269 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-07-31

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.

Conditions

Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cymbalta

Cymbalta

Intervention Type: DRUG

Interventions

Cymbalta

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are of Filipino race
• Are male or female outpatients at least 18 years of age
• Provide written consent to the release of their data after being informed of the study
• Are known diabetics and have been clinically diagnosed by the investigator to have Diabetic Peripheral Neuropathic Pain
• Are judged by the investigator to be reliable, and agree to keep appointments for clinic visits, complete tests and procedures as may be required by his/her attending physician in the course of routine clinical care
• Treated with duloxetine according to the approved Product Information as prescribed by the investigator in the routine care of the patient, without the concomitant conditions and medications specified therein as contraindicated

Exclusion Criteria

• Are the investigators or their immediate families. Immediate family was defined as the investigator's spouse, parents, naturally or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible
• Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
• Are hypersensitive to duloxetine or any of its components
• Are pregnant and/or nursing mothers
• Have concomitant conditions contraindicated for duloxetine treatment, as described in the Product Information (e.g. liver disease resulting in hepatic impairment, severe renal impairment)
• Are concomitantly taking contraindicated medications, as described in the Product Information (e.g. fluvoxamine, ciprofloxacin)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1208.31

Identifier Type: -

Identifier Source: org_study_id