NCT01015235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

Enrollment Period

1.2 years

First QC Date

November 16, 2009

Last Update Submit

August 31, 2011

Conditions

Pain, Postoperative

Keywords

Ketorolac / therapeutic useAnalgesics. Non-narcotic / therapeutic useArthroplasty, replacement hipArthroplasty, replacement kneePain measurement / drug effectPain postoperative / drug therapy

Outcome Measures

Primary Outcomes (1)

  • The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).

    Post operative Day 1

Secondary Outcomes (4)

  • 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

  • The effect of KAI-1678 on total quality analgesia

    Post-operative Day 1

  • The effect of KAI-1678 on time to meaningful pain relief

    Post-operative Day 1

Study Arms (3)

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

PlaceboDRUG

Subcutaneous infusion-once over 4 hours

Arm 1: Placebo
KAI-1678DRUG

Subcutaneous infusion-once over 4 hours

Also known as: Active drug
A2: KAI-1678
Ketorolac TromethamineDRUG

Active comparator, IV infusion, once

Also known as: Ketorolac
A3: Ketorolac

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

KAI-1678Bulk DrugsKetorolac TromethamineKetorolac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gregory Bell, MD

    KAI Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 18, 2009

Study Start

December 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 2, 2011

Record last verified: 2011-08

Locations

NZ(1)