Comparison of Pain Sensation During Single Use of Two Top... | NCT00869219

Studies
Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

NCT00869219

Sponsor

Santa Casa de Misericordia de Santos

Status

Unknown status

Last Update Posted

Mar 26, 2009Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Pain

Interventions

Nevanac
Acular LS

Countries

Brazil

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Aug 2009Estimated

Completion Date

Aug 2009Estimated

First Submitted Date

Mar 23, 2009

First Submission Date that Met QC Criteria

Mar 24, 2009

First Posted Date

Mar 25, 2009Estimated

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

Mar 25, 2009

Last Update Posted Date

Mar 26, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nevanac	Active Comparator		Drug: Nevanac
Acular LS	Active Comparator		Drug: Acular LS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nevanac	Drug	1 drop of NEVANAC at random eye	Nevanac
Acular LS

Measure	Description	Time Frame
Pain after instilation		5 min

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient over 21 years old
No ocular surface pathology
Eligible for cataract surgery

Exclusion Criteria:

Any other eye pathology other than cataract

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gustavo T Grottone, MD, MBA, MSc	Contact	551381515130		gtg2001@terra.com.br

Overall Officials

Name	Affiliation	Role
Gustavo T Grottone, MD, MBA,MSc	SCMS	Principal Investigator
João C Grottone, MD, MBA	SCMS	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santa Casa de Misericordia de Santos	Recruiting	Santos	São Paulo	11055360	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C414203	nepafenac
D020910	Ketorolac

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided