Post-Marketing Surveillance Study on the Safety and Effic... | NCT02215798

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

NCT02215798

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Aug 22, 2014Estimated

Enrollment

269Actual

Phase

Not provided

Conditions

Pain

Interventions

Cymbalta

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Oct 2009Actual

Completion Date

Not provided

First Submitted Date

Aug 12, 2014

First Submission Date that Met QC Criteria

Aug 12, 2014

First Posted Date

Aug 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2014

Last Update Posted Date

Aug 22, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

269Actual

Label	Type	Description	Intervention Names
Cymbalta			Drug: Cymbalta

Name	Type	Description	Arm Group Labels	Other Names
Cymbalta	Drug		Cymbalta

Measure	Description	Time Frame
Frequency of serious and non-serious adverse events		up to 8 weeks

Measure	Description	Time Frame
Change from baseline in Brief Pain Inventory (BPI)		up to 8 weeks
Change from baseline in Neuropathic Pain Questionnaire (NPQ)		up to 8 weeks

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatients

Sampling Method

Non-Probability Sample

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring