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

NCT07682558 | Not Yet Recruiting Phase 3

• 1 other identifier: 2026-00784; ex23gaertner
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Pain; Cancer Palliative Care

Outcome Measures

Primary Outcomes (1)

• Change in cancer pain

  The primary outcome will help to determine whether adding metamizole (dipyrone) or ibuprofen to opioids is more effective than adding placebo in reducing average daily pain intensity (primary outcome) in cancer patients. \- Average of 5-day average daily patient reported pain assessed on days 3 to 7 by numeric rating scale (NRS); The NRS ranges from 0 ("no pain") to 10 ("pain as bad as the patient can imagine")

  up to 5 days

Secondary Outcomes (15)

• Assessment of equivalence of metamizole and ibuprofen in analgesic potency regarding the pain intensity

  up to 5 days

• Worst pain in the past 24 hours by NRS

  up to 8 days

• Least pain in the past 24 hours by NRS

  up to 8 days

• Daily differences in pain intensity measured by NRS

  up to 7 days

• Patient's Individual Primary Goal (IPG) achieved

  8 days

Other Outcomes (14)

• Number of patients with ≥30% reduction in pain

  up to 7 days

• Adherence to protocol and IMP intake

  up to 7 days

• Number of participants that opened the capsules

  up to 8 days

Study Arms (3)

Opioid + Metamizole

EXPERIMENTAL

Drug: Metamizole

Opioid + Ibuprofen

EXPERIMENTAL

Drug: Ibuprofen

Opioid + Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Metamizole DRUG

Metamizole 4 g/d as: 2 capsules of 500 mg Metamizole each (1000 mg) taken 4 x daily orally.

Opioid + Metamizole

Ibuprofen DRUG

Ibuprofen 1.2 g/d as: 2 capsules of 150 mg Ibuprofen each (300 mg) taken 4 x daily orally

Opioid + Ibuprofen

Placebo OTHER

Placebo 0 g/d as: 2 capsules containing inactive substance (mannitol) taken 4 x daily orally.

Opioid + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss GO Trial Group: collaborator
• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Dipyrone; Ibuprofen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Christopher Böhlke, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Böhlke, Prof. Dr.

CONTACT

+41 61 265 25 25,; christopher.boehlke@unibas.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, randomized, double-blind, placebo-controlled, three-armed superiority trial with a 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

CH (1)