Trials Sponsors Conditions Drugs Pricing

Conditions

Erosive osteoarthritis of the hands

Outcome Measures

Primary Outcomes (1)

Difference in pain intensity (PID) of the most affected hand with respect to baseline pain at 8 weeks of treatment with different doses of Montelukast of 5, 10, 15 and 30 mg, compared to placebo, measured through the Visual Analogue Scale (VAS).

Secondary Outcomes (11)

EFFICACY ENDPOINTS:The PID with respect to baseline pain of the most affected hand at 4 weeks of treatment with different doses of Montelukast of 5, 10, 15 and 30 mg, compared to placebo, measured through the VAS
Difference in the score of AUSCAN subscales (pain, stiffness and physical function) of the most affected hand with respect to baseline at 4 and 8 weeks of treatment with different doses of Montelukast of 5, 10, 15 and 30 mg, compared to placebo.
Difference in the hand grip strength of the most affected hand with respect to baseline at 4 and 8 weeks of treatment with different doses of Montelukast 5, 10, 15 and 30 mg, compared to placebo, measured using a dynamometer (previously inflated to 60 mmHg).
Proportion of patients using rescue medication at 4 and 8 weeks of treatment with different doses of Montelukast 5, 10, 15 and 30 mg, compared to placebo.
Amount of rescue medication used in each treatment group, compared to placebo at 4 and 8 weeks of treatment with different doses of Montelukast 5, 10, 15 and 30 mg.
+6 more secondary outcomes

Interventions

Montelukast BType not reported

Montelukast DType not reported

PlaceboType not reported

Registry intervention entries

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

Formulated product
Montelukast B
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
HARD CAPSULES
View registry record
Formulated product
Montelukast D
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
HARD CAPSULES
View registry record
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
Formulated product
Montelukast A
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 B
Named ingredient: montelukast
View registry record
Montelukast D
Named ingredient: montelukast
View registry record
Montelukast C
Named ingredient: montelukast
View registry record
Montelukast A
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 and are willing to comply with all scheduled visits and procedures required by the study.
Patients ≥ 18 years at the time of the baseline visit.
Patients with erosive osteoarthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah criteria.

Sponsors & Collaborators

Farmalider S.A.
Industrylead

Study Sites (5)

Hospital Universitari Mutua Terrassa

Terrassa, 08221, Spain

Georgina Salvador Alarcon0034937365050 gsalvador@mutuaterrassa.cat

Hospital Quironsalud Infanta Luisa

Sevilla, 41010, Spain

Nadia Abdel-Kader Martin0034954330100 reumatologia@quironsalud.es

Hospital Del Mar

Barcelona, 08003, Spain

Jordi Monfort Faure0034932483332

Central Study Contacts

María Angeles Rodríguez

+34916612335 angelesrodriguez@farmalider.com

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

August 1, 2023

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: 2023-506137-30-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 03:52:02 UTC

Documents

HOME_CSR Summary_SP

You may not qualify if:

History of fibromyalgia and/or chronic fatigue syndrome.
Patient with pathologies that according to medical criteria discourage their participation in the study, such as poorly controlled neuropsychiatrics diseases, severe heart disease, liver failure, kidney failure, active malignancies, poorly controlled endocrine-metabolic diseases, coagulopathies, active gastrointestinal ulceration, active infection, epilepsy, and immunocompromised patients.
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).
Pain in another part of the body that could interfere with the evaluation and results of the study according investigator criteria.
Patient taking corticosteroids (oral or injectable) within 4 weeks prior to the baseline visit, or methotrexate, hydroxychloroquine or SYSADOAs (Slow-Acting Drugs for the Symptomatic Treatment of Osteoarthritis) within 12 weeks prior to the baseline visit.
Patients who have used intra-articular hyaluronic acid (in the study hand) during the 24 weeks prior to the baseline visit.
Patient undergoing radioactive synoviorthesis (in the study hand).
Patient being treated with other disease-modifying anti-rheumatic biological drugs.
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. *The sporadic use of Ibuprofen in case of an intercurrent disease other than EHOA will be allowed up to 96 hours prior to the screening visit (visit 0), or, to the visit 1. Maximum daily dose of ibuprofen allowed will be 1200mg.
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
+1 more criteria

A randomized, multi-centre, double-blind, phase II clinical trial of dose finding of Montelukast in patients with erosive osteoarthritis of the hands. HOME study.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

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)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations