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
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.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 11 is below the median of 91 across 21 interventional studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
5 mg ketamine all 5 minutes, maximal 4 times an hour
Drug: Ketamine · Drug: Placebo · Drug: Chitosan
see above
Drug: Morphine · Drug: Ketamine · Drug: Chitosan
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
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
This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Morphine · Ketamine · Chitosan
University Hospital, Basel, Switzerland →