Trials Sponsors Conditions Drugs Pricing

Conditions

Erosive/inflammatory osteoarthritis of the hands

Outcome Measures

Primary Outcomes (1)

Difference in pain intensity (PID) at rest of the most affected hand with respect to baseline pain at 24 weeks of treatment with Montelukast xx mg, compared to placebo, measured through the VAS.

Interventions

Montelukast CType not reported

PlaceboType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Montelukast C
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
HARD CAPSULES
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Montelukast C
Named ingredient: montelukast
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who provide written informed consent (IC) and are able to comply with all scheduled visits and procedures required by the study.
Patients ≥ 18 years at the screening visit.
Patients with erosive osteoarthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah criteria (Anandarajah, A. 2010).

Sponsors & Collaborators

Farmalider S.A.
Industrylead

Study Sites (21)

Unidade Local De Saude Do Alto Minho E.P.E.

Ponte De Lima, 4990-041, Portugal

Jose Costa+351258802100 adriana.rodrigues@blueclinical.pt

Unidade Local De Saude Da Regiao De Aveiro E.P.E.

Aveiro, 3814-501, Portugal

Maria Inês Candal Ribeiro da Cunha+351234378300 m.cunha.11337@ulsra.min-saude.pt

Hospital De Santa Maria E.P.E.

Lisbon, 1649-028, Portugal

Fernando Saraiva

Central Study Contacts

Carlos Calandria

+34916612335 carloscalandria@farmalider.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

July 3, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-521802-17-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:20:33 UTC

Documents

D4_ Patient facing doc_diary_ENG

You may not qualify if:

History of fibromyalgia and/or chronic fatigue syndrome.
Patient being treated with any other medication contraindicated due to risk of interactions with study medication.
Patient being treated with NSAIDs and/or analgesics (except paracetamol) or colchicine within 7 days prior to the baseline visit. The use of paracetamol will be allowed up to 24 hours prior to the start of study treatment.
Patient with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients.
Patient intolerant to study medication due to galactose intolerance, lactase insufficiency, or glucose-galactose malabsorption.
Pregnant or lactating women.
Patient currently included in or who have participated in a clinical trial with medicines or health products in the 3 months prior to the baseline visit.
Patients with scheduled surgery during the clinical trial.
History of drug or alcohol abuse during the 12 months prior to the baseline visit.
Patients with any contraindication related to the performance of the MRI test, including: • Pacemakers or neurostimulators, • Metal plates or fragments not attached to the bone in risk areas, newly implanted heart valves or intracranial clips. • Claustrophobia. • Weight more than 120 kg. • Intolerance to paramagnetic contrast.
Patient with pathologies that according to medical criteria discourage their participation in the study, such as severe heart disease, liver failure, kidney failure, active malignancies, poorly controlled endocrine-metabolic diseases, coagulopathies, active gastrointestinal ulceration, active infection, epilepsy, and immunocompromised patients.
Patients who, in the opinion of the investigator, are unable or not willing to comply with study and follow-up procedures.
Patient with a history of concurrent rheumatic articular diseases (history and/or current presence of signs) that could lead to a misinterpretation or interfere in the evaluation of efficacy in pain, such as chondrocalcinosis, Paget's disease of the ipsilateral extremity in relation to the affected hand, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis and disease Inflammatory bowel (Crohn's disease or Ulcerative Colitis).
Patient with a BMI ≥ 35 kg/m2.
Pain in another part of the body that could interfere with the evaluation and results of the study according to investigator criteria.
+6 more criteria

RANDOMISED, MULTICENTRE, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MONTELUKAST VS. PLACEBO IN PATIENTS WITH EROSIVE/INFLAMMATORY OSTEOARTHRITIS OF THE HANDS. MOTHER Study.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations