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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Terminated

CT.gov ID

NCT02591017

Collaborator

(none)

Enrollment

Location

Arms

29.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer: Breakthrough Pain Cancer: Extreme Pain on Movement	Drug: Morphine Drug: Ketamine Drug: Placebo Drug: Chitosan	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: morphine drops solo and placebo spray morphine 2% drops daily fixed dose of morphine equivalents < 100 mg, 0.2 mg/kg Body weight morphine drops every hour in reserve due to international Standards 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
Other: ketamine/chitosan spray nasal and placebo drops 5 mg ketamine all 5 minutes, maximal 4 times an hour	Drug: Ketamine Drug: Placebo Drug: Chitosan
Other: morphine drops and ketamine/chitosan spray nasal see above	Drug: Morphine Drug: Ketamine Drug: Chitosan

Arm

Intervention/Treatment

Other: morphine drops solo and placebo spray

morphine 2% drops daily fixed dose of morphine equivalents < 100 mg, 0.2 mg/kg Body weight morphine drops every hour in reserve due to international Standards 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

Other: ketamine/chitosan spray nasal and placebo drops

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

Drug: Ketamine

Drug: Placebo

Drug: Chitosan

Other: morphine drops and ketamine/chitosan spray nasal

see above

Drug: Morphine

Drug: Ketamine

Drug: Chitosan

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pain Relief Unit and Anaesthesiology, University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Wilhelm Ruppen, PD Dr. med., Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT02591017

Other Study ID Numbers:

EKNZ 2014-249

First Posted:

Oct 29, 2015

Last Update Posted:

Nov 13, 2018

Last Verified:

Nov 1, 2018

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2018