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

A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015235

Enrollment

Registered

2009-11-18

Start date

2008-12-31

Completion date

2010-02-28

Last updated

2011-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Ketorolac / therapeutic use, Analgesics. Non-narcotic / therapeutic use, Arthroplasty, replacement hip, Arthroplasty, replacement knee, Pain measurement / drug effect, Pain postoperative / drug therapy

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.

Interventions

DRUGPlacebo

Subcutaneous infusion-once over 4 hours

DRUGKAI-1678

Subcutaneous infusion-once over 4 hours

DRUGKetorolac Tromethamine

Active comparator, IV infusion, once

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	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
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

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026