Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery

Hospira

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Placebo; Drug: PMI-150 (intranasal ketamine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709436

KET-017

Details and patient eligibility

About

The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

Full description

Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.

Enrollment: 250 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient is scheduled for elective orthopedic surgery or procedure

Exclusion criteria

• patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter.

Treatment:

Drug: PMI-150 (intranasal ketamine)

2

Placebo Comparator group

Description:

Placebo at time 0 and specified time points thereafter.

Treatment:

Drug: Placebo