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

NCT02215798 | Completed

• 1 other identifier: 1208.31
• Study Type: observational
• Target: 269
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Frequency of serious and non-serious adverse events

  up to 8 weeks

Secondary Outcomes (2)

• Change from baseline in Brief Pain Inventory (BPI)

  up to 8 weeks

• Change from baseline in Neuropathic Pain Questionnaire (NPQ)

  up to 8 weeks

Study Arms (1)

Cymbalta

Drug: Cymbalta

Interventions

Cymbalta DRUG

Cymbalta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: July 1, 2006
• Primary Completion: October 1, 2009
• Last Updated: August 22, 2014

Record last verified: 2014-08