Safety and Efficacy Study of KAI-1678 to Treat Subjects W... | NCT01015235

Studies
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

NCT01015235

Sponsor

KAI Pharmaceuticals

Status

Completed

Last Update Posted

Sep 2, 2011Estimated

Enrollment

90Actual

Phase

Phase 2

Conditions

Pain, Postoperative

Interventions

Placebo
KAI-1678
Ketorolac Tromethamine

Countries

New Zealand

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 2011

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

Dec 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 17, 2009

First Posted Date

Nov 18, 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

Aug 31, 2011

Last Update Posted Date

Sep 2, 2011Estimated

Name	Class
Trident Clinical Research Pty Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Placebo	Placebo Comparator	Placebo	Drug: Placebo
A2: KAI-1678	Active Comparator	Test Drug	Drug: KAI-1678
A3: Ketorolac	Active Comparator	Active Comparator	Drug: Ketorolac Tromethamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Subcutaneous infusion-once over 4 hours	Arm 1: Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).		Post operative Day 1

Secondary Outcomes

Measure	Description	Time Frame
The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)		Post operative Day 1
The effect of KAI-1678 on pain intensity difference (PID) at 4 hours		Post-operative Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologist (ASA) classification 1, 2, or 3
total hip or total knee replacement
pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)

Exclusion Criteria:

presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
recent history of angina or myocardial infarction (MI)
clinically significant abnormality on laboratory tests or electrocardiogram (ECG)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gregory Bell, MD	KAI Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

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

Intervention Browse Module

MeSH Terms

ID	Term
C584124	KAI-1678
D000095485	Bulk Drugs
D020911	Ketorolac Tromethamine
D020910	Ketorolac

Ancestor Terms

ID	Term
D004364	Pharmaceutical Preparations
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided