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Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients

NCT02591017 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-11-13

No results posted yet for this study

Summary

34 adult (\>18 years) cancer pain outpatients with Opioid base therapy because of pain and breakthrough pain or extreme pain on movement will be included in this prospective, randomized, double-blind crossover study.

Over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one week: Group A receives morphine drops and Placebo spray, Group B receives ketamine/chitosan spray nasal and Placebo drops and Group C receives morphine drops and ketamine/chitosan spray nasal.

Primary endpoint is time to onset of action of intranasal ketamine compared with morphine drops. Secondary endpoint is the median numeric rating scale (NRS) improvement after using the spray or morphine or the combination of ketamine spray and morphine drops.

Conditions

  • Cancer: Breakthrough Pain
  • Cancer: Extreme Pain on Movement

Interventions

DRUG

Morphine

DRUG

Ketamine

DRUG

Placebo

DRUG

Chitosan

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Wilhelm Ruppen, PD Dr. med. · Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-07-31
Completion
2017-07-06

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591017 on ClinicalTrials.gov