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Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain

IMPORTANCE Trial - A Provisional Study-design of a Single-center, Phase II, Double-blinded, Placebo-controlled, Randomized, 4-week Study to Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain

NCT04666623•University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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.
+9 more criteria

Locations (1)

University Hospital Basel, Klinik für Mund-, Kiefer- und Gesichtschirurgie

Basel, Switzerland

Key Dates

Start Date

November 25, 2020

Primary Completion Date

October 11, 2023

Completion Date

October 11, 2023

Last Updated

October 19, 2023

Conditions

Cancer Pain

Interventions

esketamine nasal spray

DRUG

placebo nasal spray

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Compare the Efficacy and Safety of Intranasal Esketamine in Chronic Opioid Refractory Pain

Inclusion Criteria

Exclusion Criteria

Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain

Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.

Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)

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UDOPAL Study: Home-Based Interventional Approach to Pain Management in Home-Hospitalized Patients