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

NCT02591017 | Terminated Phase 3

• 1 other identifier: EKNZ 2014-249
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Time to onset of action of intranasal ketamine compared with morphine drops

  5 minutes

• Time to onset of action of intranasal ketamine compared with morphine drops

  10 minutes

• Time to onset of action of intranasal ketamine compared with morphine drops

  15 minutes

• Time to onset of action of intranasal ketamine compared with morphine drops

  20 minutes

• Time to onset of action of intranasal ketamine compared with morphine drops

  45 minutes

Secondary Outcomes (4)

• Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops

  after 5, 10, 15, 20, 45 minutes

• Total amount of delivered applications of ketamine or morphine in each study arm

  3 weeks

• Total amount of fixed and reserve opioid doses increase in each study arm

  3 weeks

• Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa

  3 weeks

Study Arms (3)

morphine drops solo and placebo spray

OTHER

morphine 2% drops 1. daily fixed dose of morphine equivalents \< 100 mg, 0.2 mg/kg Body weight morphine drops every hour in reserve due to international Standards 2. daily fixed dose of morphine equivalents =/\> 100 mg, 15% of the fixed daily dose in morphine drops every hour in reserve due to international standards

Drug: Morphine; Drug: Placebo

ketamine/chitosan spray nasal and placebo drops

OTHER

5 mg ketamine all 5 minutes, maximal 4 times an hour

Drug: Ketamine; Drug: Placebo; Drug: Chitosan

morphine drops and ketamine/chitosan spray nasal

OTHER

see above

Drug: Morphine; Drug: Ketamine; Drug: Chitosan

Interventions

Morphine DRUG

morphine drops and ketamine/chitosan spray nasal; morphine drops solo and placebo spray

Ketamine DRUG

ketamine/chitosan spray nasal and placebo drops; morphine drops and ketamine/chitosan spray nasal

Placebo DRUG

ketamine/chitosan spray nasal and placebo drops; morphine drops solo and placebo spray

Chitosan DRUG

ketamine/chitosan spray nasal and placebo drops; morphine drops and ketamine/chitosan spray nasal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer pain in outpatients with:
• Opioid based therapy due to pain
• Breakthrough pain or
• Extreme pain on movement
• Age \>= 18 years

You may not qualify if:

• Patients unable to give written informed consent
• Patients unable to understand how to handle and document the use of the study medication
• Known drug allergies or intolerance to ketamine
• Known drug allergies or intolerance to morphine
• Known allergy to crustacea or chitosan
• Patients using snuff at a regular basis
• Recreational drug addiction or abuse
• Serious intranasal or epipharyngeal Problems (Septum wall defects, cancer)
• Mental/psychiatric disorder
• Patients with renal failure (clearance \< 30 ml/min)
• Pregnancy and breast feeding mothers
• Patients not understanding German
• Patient having arterial hypertonia with measured values \> 180/95

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Pain Relief Unit and Anaesthesiology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Morphine; Ketamine; Chitosan

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Wilhelm Ruppen, PD Dr. med.

  Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: October 29, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 6, 2017
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

CH (1)