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

2023-504143-14-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 2 May 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 10 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 76
Countries 1
Sites 10

Chronic pancreatitis

To study if adding metamizole three times daily at a dosage of 1000mg to the current analgesic therapy effectively reduce pain in patients with painful chronic pancreatitis, with time since diagnosis of less than 3 years

Key facts

Sponsor
Stichting Radboud University Medical Center, Stichting Radboud University Medical Center
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06]
Trial duration
2 May 2024 → ongoing
Decision date (initial)
2023-10-11
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To study if adding metamizole three times daily at a dosage of 1000mg to the current analgesic therapy effectively reduce
pain in patients with painful chronic pancreatitis, with time since diagnosis of less than 3 years

Conditions and MedDRA coding

Chronic pancreatitis

VersionLevelCodeTermSystem organ class
20.1 LLT 10009093 Chronic pancreatitis 10017947

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Intervention phase
During the intervention phase, all patients receive the investigational medicinal product (either oral metamizol or oral placebo) in addition to their current analgesic therapy.
 Randomised Controlled Double [{"id":111676,"code":2,"name":"Investigator"},{"id":111680,"code":4,"name":"Analyst"},{"id":111677,"code":5,"name":"Carer"},{"id":111678,"code":1,"name":"Subject"},{"id":111679,"code":3,"name":"Monitor"}] Metamizole group: Patients receiving current analgesic therapy combined with oral metamizol three times daily at a dosage of 1000mg
Control group: Patients receiving current analgesic therapy combined with oral placebo three times daily

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Confirmed chronic pancreatitis
  2. Abdominal pain typical for chronic pancreatitis (i.e. dull epigastric pain), NRS ≥ 3, ≥ 3 days/week for two weeks

Exclusion criteria 7

  1. Endoscopic or surgical intervention < 3 months prior to inclusion
  2. Expected endoscopic or surgical intervention for CP within trial duration (6 weeks)
  3. Usage of more than 90 morphine milligram equivalents per day
  4. Active use of metamizole at inclusion
  5. Contra-indications to metamizole
  6. Pancreatic carcinoma
  7. • Start of amitriptyline, pregabalin or gabapentin less than 6 weeks prior to inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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 endpoints 10

  1. Izbicki pain score
  2. COMPAT-SF
  3. mean of maximum daily pain intensity score
  4. number of patients achieving successful pain reduction
  5. number of pain free days
  6. number of days with acceptable pain
  7. total amount of milligrams morphine equivalent (MME) and MME required as escape medication
  8. QoL (PANQOLI and SF-36)
  9. patient satisfaction (PGIC)
  10. side effects

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Dolamizol 500 mg tablet

PRD9228341 · Product

Active substance
Metamizole Sodium Monohydrate
Substance synonyms
DIPYRONE MONOHYDRATE
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
4000 mg milligram(s)
Max total dose
56000 mg milligram(s)
Max treatment duration
2 Week(s)
Authorisation status
Authorised
ATC code
N02BB02 — METAMIZOLE SODIUM
Marketing authorisation
RVG 124160
MA holder
ALLGEN PHARMACEUTICALS & GENERICS BV
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
A water-soluble, pH-independent film coating

Placebo 1

Placebo metamizole sodium monohydrate 500 mg film-coated tablet

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud University Medical Center

21 Total trials 11 Recruiting 9 Ended
Academic / Non-commercial
Sponsor organisation
Stichting Radboud University Medical Center
Address
Geert Grooteplein Zuid 10
City
Nijmegen
Postcode
6525 GA
Country
Netherlands

Scientific contact point

Organisation
Stichting Radboud University Medical Center
Contact name
Drs. N.D.E. Thierens

Public contact point

Organisation
Stichting Radboud University Medical Center
Contact name
Drs. N.D.E. Thierens

Stichting Radboud University Medical Center

21 Total trials 11 Recruiting 9 Ended
Academic / Non-commercial
Sponsor organisation
Stichting Radboud University Medical Center
Address
Geert Grooteplein Zuid 10
City
Nijmegen
Postcode
6525 GA
Country
Netherlands

Locations

1 EU/EEA country · 10 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruiting 76 10
Rest of world — 0 —

Investigational sites

Netherlands

10 sites · Ongoing, recruiting
Gelre Hospitals
Gastroenterology and Hepatology, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
University Hospital Maastricht
Surgery, P Debyelaan 25, 6229 HX, Maastricht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Gastroenterology and Hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
St. Antonius Ziekenhuis
Gastroenterology and Hepatology, Koekoekslaan 1, 3435 CM, Nieuwegein
Medisch Spectrum Twente
Gastroenterology and Hepatology, Koningsplein 1, 7512 KZ, Enschede
Stichting Radboud University Medical Center
Gastroenterology and Hepatology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amsterdam UMC
Gastroenterology and Hepatology, De Boelelaan 1117, 1081 HV, Amsterdam
Maasstad Ziekenhuis Stichting
Gastroenterology and Hepatology, Maasstadweg 21, 3079 DZ, Rotterdam
Treant Ziekenhuiszorg Stichting
Gastroenterology and Hepatology, Boermarkeweg 60, 7824 AA, Emmen
Bravis Ziekenhuis
Gastroenterology and Hepatology, Boerhaavelaan 25, 4708 AE, Roosendaal

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-05-02 2024-05-02

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_ SIS and ICF adults 2.3

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-07-18 Netherlands Acceptable
2023-10-11
 2023-10-11
2 SUBSTANTIAL MODIFICATION SM-1 2024-04-26 Netherlands Acceptable 2024-06-03
3 SUBSTANTIAL MODIFICATION SM-2 2024-06-14 Netherlands Acceptable
2024-07-10
 2024-07-11
4 SUBSTANTIAL MODIFICATION SM-3 2025-02-25 Netherlands Acceptable 2025-03-31

Related clinical trials