Status:
COMPLETED
Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pain
Eligibility:
All Genders
18+ years
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 th...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT02215798
Start Date
July 1 2006
Last Update
August 22 2014
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