Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain (NCT04666623) | Clinical Trial Compass
WithdrawnPhase 2
Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain
Stopped: investigator decision
Switzerland0Started 2020-11-25
Plain-language 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 of adult patients with severe and opioid refractory chronic cancer pain.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* History of allergy or intolerance to esketamine or ketamine.
* History of allergy to disinfecting products conta…
What they're measuring
1
Change in the eleven point Numeric Pain Rating Scale (NPRS)
Timeframe: 4 consecutive weeks (from Baseline to week 4)