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

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ClinicalTrials.gov Identifier: NCT02591017
Recruitment Status : Terminated (insufficient enrollment)
First Posted : October 29, 2015
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer: Breakthrough Pain Cancer: Extreme Pain on Movement Drug: Morphine Drug: Ketamine Drug: Placebo Drug: Chitosan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
Study Start Date : February 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
ketamine/chitosan spray nasal and placebo drops
5 mg ketamine all 5 minutes, maximal 4 times an hour
Drug: Ketamine
Drug: Placebo
Drug: Chitosan
morphine drops and ketamine/chitosan spray nasal
see above
Drug: Morphine
Drug: Ketamine
Drug: Chitosan



Primary Outcome Measures :
  1. Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: 5 minutes ]
  2. Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: 10 minutes ]
  3. Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: 15 minutes ]
  4. Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: 20 minutes ]
  5. Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: 45 minutes ]

Secondary Outcome Measures :
  1. 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 ]
  2. Total amount of delivered applications of ketamine or morphine in each study arm [ Time Frame: 3 weeks ]
  3. Total amount of fixed and reserve opioid doses increase in each study arm [ Time Frame: 3 weeks ]
  4. Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591017


Locations
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Switzerland
Pain Relief Unit and Anaesthesiology, University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Wilhelm Ruppen, PD Dr. med. Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02591017     History of Changes
Other Study ID Numbers: EKNZ 2014-249
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Cancer Pain
Breakthrough Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ketamine
Chitosan
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics