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NCT07682558Not yet recruiting

Efficacy of Non-opioid Drugs in Addition to Opioid Therapy for Cancer Pain Management

Summary

The investigators investigate the efficacy of non-opioid analgesics compared to placebo together with opioid therapy for cancer pain management.

Inclusion criteria

• 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

Exclusion criteria

• 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

The trial team's contact details are shown on request.

See the official trial record
Status
Not yet recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland
Sponsor
University Hospital, Basel, Switzerland(Other)
Protocol no.
2026-00784; ex23gaertner
Conditions
Cancer Pain, Cancer Palliative Care
Interventions
Drug, Other

Treatments studied

  • Metamizole
  • Ibuprofen
  • Placebo

Collaborators

Swiss GO Trial Group, Swiss National Science Foundation

Locations · 1

  • Basel, SwitzerlandUniversity Hospital BaselNot yet recruiting at this site

In total, worldwide, the only site listed in the registry is planned; recruitment has not opened yet.

Site status per the ClinicalTrials.gov registry (last update posted: August 19, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.