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Trial record 54 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

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

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ClinicalTrials.gov Identifier: NCT02215798
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 22, 2014
Sponsor:
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

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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

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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
Outpatients
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)

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02215798     History of Changes
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:
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Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents