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

Primary Purpose

Cancer: Breakthrough Pain, Cancer: Extreme Pain on Movement

Status

Terminated

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Morphine

Ketamine

Placebo

Chitosan

About this trial

This is an interventional treatment trial for Cancer: Breakthrough Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pain Relief Unit and Anaesthesiology, University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

morphine drops solo and placebo spray

ketamine/chitosan spray nasal and placebo drops

morphine drops and ketamine/chitosan spray nasal

Arm Description

morphine 2% drops daily fixed dose of morphine equivalents < 100 mg, 0.2 mg/kg Body weight morphine drops every hour in reserve due to international Standards 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

5 mg ketamine all 5 minutes, maximal 4 times an hour

see above

Outcomes

Primary Outcome Measures

Time to onset of action of intranasal ketamine compared with morphine drops

Secondary Outcome Measures

Median NRS improvement after using the spray or morphine or the combination of ketamine spray and morphine drops

Total amount of delivered applications of ketamine or morphine in each study arm

Total amount of fixed and reserve opioid doses increase in each study arm

Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa

Full Information

NCT ID

NCT02591017

First Posted

April 1, 2015

Last Updated

November 8, 2018

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT02591017

Brief Title

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

Acronym

ONKEMI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Terminated

Why Stopped

insufficient enrollment

Study Start Date

February 2015 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer: Breakthrough Pain, Cancer: Extreme Pain on Movement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

morphine drops solo and placebo spray

Arm Type

Other

Arm Description

Arm Title

ketamine/chitosan spray nasal and placebo drops

Arm Type

Other

Arm Description

5 mg ketamine all 5 minutes, maximal 4 times an hour

Arm Title

morphine drops and ketamine/chitosan spray nasal

Arm Type

Other

Arm Description

see above

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Chitosan

Primary Outcome Measure Information:

Title

Time to onset of action of intranasal ketamine compared with morphine drops

Time Frame

5 minutes

Title

Time to onset of action of intranasal ketamine compared with morphine drops

Time Frame

10 minutes

Title

Time to onset of action of intranasal ketamine compared with morphine drops

Time Frame

15 minutes

Title

Time to onset of action of intranasal ketamine compared with morphine drops

Time Frame

20 minutes

Title

Time to onset of action of intranasal ketamine compared with morphine drops

Time Frame

45 minutes

Secondary Outcome Measure Information:

Title

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

Title

Total amount of delivered applications of ketamine or morphine in each study arm

Time Frame

3 weeks

Title

Total amount of fixed and reserve opioid doses increase in each study arm

Time Frame

3 weeks

Title

Assessment of Nausea, vomiting, itching, fatigue, hallucinations, Irritation of nasal mucosa

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilhelm Ruppen, PD Dr. med.

Organizational Affiliation

Pain Relief Unit and Anaesthesiology, University Hospital Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pain Relief Unit and Anaesthesiology, University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

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

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