Cancer: Breakthrough Pain Clinical Trial
— ONKEMIOfficial title:
Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
| Verified date | November 2018 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 11 |
| Est. completion date | July 6, 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Pain Relief Unit and Anaesthesiology, University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to onset of action of intranasal ketamine compared with morphine drops | 5 minutes | ||
| Primary | Time to onset of action of intranasal ketamine compared with morphine drops | 10 minutes | ||
| Primary | Time to onset of action of intranasal ketamine compared with morphine drops | 15 minutes | ||
| Primary | Time to onset of action of intranasal ketamine compared with morphine drops | 20 minutes | ||
| Primary | Time to onset of action of intranasal ketamine compared with morphine drops | 45 minutes | ||
| Secondary | 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 | ||
| Secondary | Total amount of delivered applications of ketamine or morphine in each study arm | 3 weeks | ||
| Secondary | Total amount of fixed and reserve opioid doses increase in each study arm | 3 weeks | ||
| Secondary | Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa | 3 weeks |