Cancer: Breakthrough PainPhase 3ONKEMINCT02591017
Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
A Phase 3 study testing Morphine, Ketamine and Chitosan in people with Cancer: Breakthrough Pain and Cancer: Extreme Pain on Movement, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer: Breakthrough Pain, Cancer: Extreme Pain on Movement
- What is being tested?
- Morphine, Ketamine and Chitosan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to 6 Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer pain in outpatients with:
- Opioid based therapy due to pain
- Breakthrough pain or
- Extreme pain on movement
- Age >= 18 years
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pain Relief Unit and Anaesthesiology, University Hospital Basel
Basel, 4031
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| morphine drops solo and placebo spray | Other | 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 Receives: Drug: Morphine; Drug: Placebo |
| ketamine/chitosan spray nasal and placebo drops | Other | 5 mg ketamine all 5 minutes, maximal 4 times an hour Receives: Drug: Ketamine; Drug: Placebo; Drug: Chitosan |
| morphine drops and ketamine/chitosan spray nasal | Other | see above Receives: Drug: Morphine; Drug: Ketamine; Drug: Chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of action of intranasal ketamine compared with morphine drops
Measured: 5 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Measured: 10 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Measured: 15 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Measured: 20 minutes
Time to onset of action of intranasal ketamine compared with morphine drops
Measured: 45 minutes
Secondary outcomes (4)
Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops
Measured: after 5, 10, 15, 20, 45 minutes
Total amount of delivered applications of ketamine or morphine in each study arm
Measured: 3 weeks
Total amount of fixed and reserve opioid doses increase in each study arm
Measured: 3 weeks
Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2017
- Study completion6 Jul 2017
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer: Breakthrough PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilhelm Ruppen, PD Dr. med., Principal investigator, Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591017
- Sponsor's protocol ID
- EKNZ 2014-249
- Acronym
- ONKEMI
- Status last verified
- Nov 2018
- First submitted
- 1 Apr 2015
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
- ClinicalTrials.gov ID
- NCT02591017
- Acronym / sponsor ID
- ONKEMI / EKNZ 2014-249
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| morphine drops solo and placebo spray | Other | Drug: Morphine, Drug: Placebomorphine 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 |
| ketamine/chitosan spray nasal and placebo drops | Other | Drug: Ketamine, Drug: Placebo, Drug: Chitosan5 mg ketamine all 5 minutes, maximal 4 times an hour |
| morphine drops and ketamine/chitosan spray nasal | Other | Drug: Morphine, Drug: Ketamine, Drug: Chitosansee above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cancer pain in outpatients with:
- Opioid based therapy due to pain
- Breakthrough pain or
- Extreme pain on movement
- Age >= 18 years
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine | Drug | morphine drops and ketamine/chitosan spray nasal, morphine drops solo and placebo spray |
| Ketamine | Drug | ketamine/chitosan spray nasal and placebo drops, morphine drops and ketamine/chitosan spray nasal |
| Placebo | Drug | ketamine/chitosan spray nasal and placebo drops, morphine drops solo and placebo spray |
| Chitosan | Drug | ketamine/chitosan spray nasal and placebo drops, morphine drops and ketamine/chitosan spray nasal |
Primary outcome
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
4 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
Results and safety
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilhelm Ruppen, PD Dr. med. principal investigator
Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Morphine, Ketamine and Chitosan in people with Cancer: Breakthrough Pain and Cancer: Extreme Pain on Movement, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of action of intranasal ketamine compared with morphine drops (time frame: 5 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.