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

KAI Pharmaceuticals90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain, Postoperative

Interventions

PlaceboDRUG

Subcutaneous infusion-once over 4 hours

KAI-1678DRUG

Subcutaneous infusion-once over 4 hours

Ketorolac TromethamineDRUG

Active comparator, IV infusion, once

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Hamilton, New Zealand

Outcomes

Primary Outcomes

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

Time frame: Post operative Day 1

Secondary Outcomes

The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)

Time frame: Post operative Day 1

The effect of KAI-1678 on pain intensity difference (PID) at 4 hours

Time frame: Post-operative Day 1

The effect of KAI-1678 on total quality analgesia

Time frame: Post-operative Day 1

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

Time frame: Post-operative Day 1

Data from ClinicalTrials.gov

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