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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02591017
Recruitment Status : Terminated (insufficient enrollment)
First Posted : October 29, 2015
Last Update Posted : November 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE April 1, 2015
First Posted Date  ICMJE October 29, 2015
Last Update Posted Date November 13, 2018
Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
  • Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: After 5 minutes ]
  • Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: After 10 minutes ]
  • Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: After 15 minutes ]
  • Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: After 20 minutes ]
  • Time to onset of action of intranasal ketamine compared with morphine drops [ Time Frame: After 45 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
Official Title  ICMJE Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer: Breakthrough Pain
  • Cancer: Extreme Pain on Movement
Intervention  ICMJE
  • Drug: Morphine
  • Drug: Ketamine
  • Drug: Placebo
  • Drug: Chitosan
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Morphine
    • Drug: Placebo
  • ketamine/chitosan spray nasal and placebo drops
    5 mg ketamine all 5 minutes, maximal 4 times an hour
    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
    • Drug: Chitosan
  • morphine drops and ketamine/chitosan spray nasal
    see above
    Interventions:
    • Drug: Morphine
    • Drug: Ketamine
    • Drug: Chitosan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 8, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2015)
34
Actual Study Completion Date  ICMJE July 6, 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02591017
Other Study ID Numbers  ICMJE EKNZ 2014-249
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wilhelm Ruppen, PD Dr. med. Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP