COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02215798
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 22, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pain Drug: Cymbalta

Layout table for study information
Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients
Study Start Date : July 2006
Actual Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Cymbalta Drug: Cymbalta

Primary Outcome Measures :
  1. Frequency of serious and non-serious adverse events [ Time Frame: up to 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Brief Pain Inventory (BPI) [ Time Frame: up to 8 weeks ]
  2. Change from baseline in Neuropathic Pain Questionnaire (NPQ) [ Time Frame: up to 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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)

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim Identifier: NCT02215798    
Other Study ID Numbers: 1208.31
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents