Status:
WITHDRAWN
Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Cancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to assess the efficacy and safety of a four-week treatment with intranasal esketamine (56 mg) twice a week combined with opioid analgesic and adjuvant standard therapy in the management ...
Eligibility Criteria
Inclusion
- Patient with refractory cancer pain, this pain defined when:
- Multiple evidence- based biomedical therapies used in a clinically appropriate and acceptable fashion have failed to reach treatment goals that mainly include adequate pain reduction and/or improvement in daily living functioning activities.
- Patients' functional activities do not allow a quality of life which is acceptable and/or pharmaceutical therapies have resulted in intolerable adverse effects.
- Psychiatric disorders and psychosocial factors that could influence pain outcomes have been assessed and appropriately addressed
- Cancer pain classified as chronic (persistent or recurrent pain lasting longer than 3 months), and currently refractory despite optimized analgesic therapy including an opioid.
- • Optimized analgesic therapy is arbitrarily defined as: oral morphine equivalent of 60 mg/d or more (or another strong opioid at optimized dose) plus at least one adjuvant analgesic drug, for at least 2 weeks.
- No increase in baseline long acting opioid dose or addition of a new adjuvant analgesic drug within 2 weeks prior to study entry
- Ability to communicate the intensity of pain using the NPRS pain scale ranging from (0 as no pain to 10 with severe pain).
- Ability to give fully informed written consent.
- Expect survival more than 3 months.
Exclusion
- History of allergy or intolerance to esketamine or ketamine.
- History of allergy to disinfecting products containing quaternary ammonium, who might be susceptible to be allergic to denatonium benzoate.
- Concomitant use of xanthine derivatives (e.g. aminophylline, theophylline), ergometrine, or monoamine oxidase inhibitors.
- Active nasal/sinus dysfunction (e.g. allergic or infectious rhinitis) or presence of any lesion of the nasal mucosa.
- Pregnancy, breastfeeding and women of childbearing potential not using a highly effective contraception method.
- Uncontrolled hypertension, arrhythmia, heart failure, or untreated coronary artery disease. History of transient ischemic attacks, stroke, neurovascular disease, hemorrhage, severe head injury, hydrocephalus or elevated intracranial pressure within the last 3 months.
- History of primary or metastatic malignant brain lesions (uncontrolled or without previous treatment).
- Known aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation
- Uncontrolled psychiatric illness with psychosis/ hallucination (e.g. schizophrenia, acute psychosis).
- Alcohol abuse, drug abuse/ dependence within the past 6 months as self-reported.
- Cirrhosis or severe hepatic impairment defined as 5-fold elevation of transaminases
- Uncontrolled hyperthyroidism.
- Globe injuries or increased intraocular pressure (e.g. glaucoma).
- History of ulcerative or interstitial cystitis.
- Subjects scheduled to receive radiotherapy (RT) to a site of pain during the study period, or who have received RT to a site of pain within 2 weeks before study entry.
- Subjects scheduled to undergo surgical treatment during the study period likely to affect pain.
- Subjects on or starting chemotherapy if there is a significant expectation of that therapy affecting pain.
- Subjects who have not provided signed informed consent form.
- Concomitant use of drugs moderately or severely affecting cytochrome P450 activity.
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04666623
Start Date
November 25 2020
End Date
October 11 2023
Last Update
October 19 2023
Active Locations (1)
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1
University Hospital Basel, Klinik für Mund-, Kiefer- und Gesichtschirurgie
Basel, Switzerland, 4031