NCT07682558Pas encore en recrutement
Efficacy of Non-opioid Drugs in Addition to Opioid Therapy for Cancer Pain Management
Résumé
The investigators investigate the efficacy of non-opioid analgesics compared to placebo together with opioid therapy for cancer pain management.
Critères d'inclusion
• Inpatient setting (discharge possible, if patient returns for End of Study Visit) • Diagnosis of metastatic or locally advanced cancer • Cancer pain as defined by IASP (International Association for the Study of Pain) • Cancer pain therapy with opioids indicated for pain management or start thereof at baseline (drug, dose, and route at treating physician's discretion) • Average daily pain intensity ≥ 3 on NRS (Numeric Rating Scale) • Ability to swallow oral medication • Informed Consent as documented by signature
Critères d'exclusion
• History of allergy or allergy-like symptoms (bronchospasm, urticaria or severe cutaneous adverse reactions (SCARs)) or hypersensitivity to dipyrone (or other pyrazolones or pyrazolidines) or ibuprofen (or other Non-steroidal anti-inflammatory drug incl. acetylsalicylic acid) • Moderate to severe renal insufficiency (creatinine-eGFR (estimated Glomerular Filtration Rate) \<45 ml/min) • Severe heart failure (New York Heart Association class III-IV) • Severe hepatic impairment (liver cirrhosis with ascites) or hepatic porphyria • History of agranulocytosis induced by dipyrone (or other pyrazolones or pyrazolidines) • Active gastric and/or duodenal ulcers or bleeding • History of recurrent gastric and/or duodenal ulcers or gastrointestinal bleeding (≥2 distinct episodes of proven ulceration or bleeding) or increased tendency to bleeding • Third trimester of pregnancy • Breastfeeding • G6PD deficiency • Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) • Intrathecal or epidural opioids or local or regional anesthetic therapy • Additional second opioid for co-analgesic effects or other reasons (e.g., methadone, buprenorphine) • Initiation of therapy with transdermal therapeutic system (TTS) opioid \<48 hours before start of IMP • Use of non-opioids with long half-life (i.e., acemetacin, celecoxib, etodolac, etoricoxib, ketorolac, naproxen, piroxicam, tenoxicam) • Pain unrelated to cancer (e.g. chronic non-cancer pain \[CNCP\], postoperative, particularly following coronary artery or cardiopulmonary bypass surgery) • Inability to follow study procedures or adhere to protocol (e.g., due to language problems, psychological disorders, dementia) • Inability to abstain from other non-opioids (apart from IMP (Investigational Medicinal Product)) during study participation • Participation in any interventional study targeted at pain management • Participant is a family member or employee of the investigator
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Pas encore en recrutement
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- University Hospital, Basel, Switzerland(Autre)
- N° de protocole
- 2026-00784; ex23gaertner
- Pathologies
- Cancer Pain, Cancer Palliative Care
- Interventions
- Médicament, Autre
Traitements évalués
- Metamizole
- Ibuprofen
- Placebo
Collaborateurs
Swiss GO Trial Group, Swiss National Science Foundation
Lieux · 1
- Basel, SuisseUniversity Hospital BaselRecrutement pas encore ouvert dans ce centre
Au total, dans le monde, le seul centre listé au registre est prévu ; le recrutement n'est pas encore ouvert.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 19 août 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.