Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
NCT ID: NCT02591017
Last Updated: 2018-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
11 participants
INTERVENTIONAL
2015-02-28
2017-07-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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
Morphine
Placebo
ketamine/chitosan spray nasal and placebo drops
5 mg ketamine all 5 minutes, maximal 4 times an hour
Ketamine
Placebo
Chitosan
morphine drops and ketamine/chitosan spray nasal
see above
Morphine
Ketamine
Chitosan
Interventions
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Morphine
Ketamine
Placebo
Chitosan
Eligibility Criteria
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Inclusion Criteria
* Opioid based therapy due to pain
* Breakthrough pain or
* Extreme pain on movement
* Age \>= 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Wilhelm Ruppen, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland
Locations
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Pain Relief Unit and Anaesthesiology, University Hospital Basel
Basel, , Switzerland
Countries
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Other Identifiers
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EKNZ 2014-249
Identifier Type: -
Identifier Source: org_study_id
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