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Metamizole as pain treatment in patients with chronic pancreatitis, a multicenter, randomized, double-blind, placebo-controlled trial.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504143-14-00
Enrollment
76
Registered
2023-10-11
Start date
2024-05-02
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pancreatitis

Brief summary

Mean daily pain intensity score, recorded during the 4-week intervention by the patient using a 11-point numerical rating (0 = no pain to 10 = worst pain imaginable)

Detailed description

Izbicki pain score, COMPAT-SF, mean of maximum daily pain intensity score, number of patients achieving successful pain reduction, number of pain free days, number of days with acceptable pain, total amount of milligrams morphine equivalent (MME) and MME required as escape medication, QoL (PANQOLI and SF-36), patient satisfaction (PGIC), side effects

Interventions

DRUGPlacebo metamizole sodium monohydrate 500 mg film-coated tablet
DRUGDolamizol 500 mg tablet

Sponsors

Stichting Radboud University Medical Center, Stichting Radboud University Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean daily pain intensity score, recorded during the 4-week intervention by the patient using a 11-point numerical rating (0 = no pain to 10 = worst pain imaginable)

Secondary

MeasureTime frame
Izbicki pain score, COMPAT-SF, mean of maximum daily pain intensity score, number of patients achieving successful pain reduction, number of pain free days, number of days with acceptable pain, total amount of milligrams morphine equivalent (MME) and MME required as escape medication, QoL (PANQOLI and SF-36), patient satisfaction (PGIC), side effects

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026