Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients

Hospira

Status and phase: Terminated; Phase 3

Conditions: Cancer; Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492388

KET-016

Details and patient eligibility

About

To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

Full description

The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 18 years of age
• Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain

Exclusion criteria

• under 18 years
• non-cancer pain
• allergy to ketamine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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2 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

PMI-150 (intranasal ketamine)

Treatment:

Drug: PMI-150 (intranasal ketamine)

B

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo