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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215798
• Other study ID #: 1208.31
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: August 21, 2014
• Start date: July 2006

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Pain

Intervention

Drug:
• Cymbalta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of serious and non-serious adverse events		up to 8 weeks	No
Secondary	Change from baseline in Brief Pain Inventory (BPI)		up to 8 weeks	No
Secondary	Change from baseline in Neuropathic Pain Questionnaire (NPQ)		up to 8 weeks	No

External Links

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