Safety and Efficacy of Intranasal Ketamine for the Treatm... | NCT00488787

Studies
Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain

NCT00488787

Sponsor

Javelin Pharmaceuticals

Status

Completed

Last Update Posted

Feb 7, 2008Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Pain, Postoperative

Interventions

intranasal ketamine
intranasal ketamine
intranasal ketamine
placebo

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

Feb 2008

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

Mar 2001

Primary Completion Date

Apr 2001Actual

Completion Date

Apr 2001Actual

First Submitted Date

Jun 19, 2007

First Submission Date that Met QC Criteria

Jun 19, 2007

First Posted Date

Jun 20, 2007Estimated

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

Feb 5, 2008

Last Update Posted Date

Feb 7, 2008Estimated

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

Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3 hours post administration and assess pain intensity and pain relief throughout the 3 hour postoperative period.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Intranasal ketamine low dose	Drug: intranasal ketamine
B	Experimental	intranasal ketamine medium dose	Drug: intranasal ketamine
C	Experimental	intranasal ketamine high dose	Drug: intranasal ketamine
D	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intranasal ketamine	Drug	low dose	A
intranasal ketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total pain relief over 0-3 hours following dosing		3 hours

Secondary Outcomes

Measure	Description	Time Frame
other pain assessments		3 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy patients at least 16 years of age requiring two or more third molar extractions

Exclusion Criteria:

Less than 16 years old
Other exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyle Christensen, DDS	Jean Brown Associates	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided