TerminatedNCT02591017ONKEMIUpdated Nov 13, 2018

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

A Phase 3 interventional study of Morphine and Ketamine in Cancer: Breakthrough Pain and Cancer: Extreme Pain on Movement, sponsored by University Hospital, Basel, Switzerland. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-13.

Sponsored by University Hospital, Basel, Switzerland · Phase 3, Interventional, and Treatment

Why this study was terminated

insufficient enrollment

Phase: Phase 3
Study type: Interventional
Enrollment: 11
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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 studied

Cancer: Breakthrough Pain
Cancer: Extreme Pain on Movement

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 11 participants (actual)

Study arms

Other
morphine drops solo and placebo spray
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
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

Interventions

DrugMorphine
DrugKetamine
DrugPlacebo
DrugChitosan

What researchers measure

Primary outcomes

Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 5 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 10 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 15 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 20 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Time frame: 45 minutes

Secondary outcomes

Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops
Time frame: after 5, 10, 15, 20, 45 minutes
Total amount of delivered applications of ketamine or morphine in each study arm
Time frame: 3 weeks
Total amount of fixed and reserve opioid doses increase in each study arm
Time frame: 3 weeks
Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa
Time frame: 3 weeks

Study locations

1 site

Pain Relief Unit and Anaesthesiology, University Hospital Basel
Basel, 4031, Switzerland

Registry details

Key details

Study ID: NCT02591017
Lead sponsor: University Hospital, Basel, Switzerland
Responsible party: Sponsor
First posted: Oct 29, 2015
Start date: Feb 2015
Primary completion: Jul 2017
Completion: Jul 6, 2017
Last update: Nov 13, 2018

Study contacts

Wilhelm Ruppen, PD Dr. med.

principal investigator · Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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