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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01091675 |
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Date of registration:
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22/03/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to =2 NSAIDs
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Scientific title:
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Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to =2 Nonsteroidal Antiinflammatory Drug (NSAID) |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01091675 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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Contacts
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Name:
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Raimon Sanmartí Sala, PhD/MD |
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Affiliation:
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Hospital Clinic i Provincial Barcelona |
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Name:
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Rosa Morlá, PhD/MD |
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Affiliation:
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Sant Pau i Santa Tecla Hospital |
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Name:
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Luis Francisco Linares Ferrando, PhD/MD |
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Affiliation:
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Virgen de la Arrixaca Hospital |
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Name:
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Rubén Queiro Silva, PhD/MD |
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Address:
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Affiliation:
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Asturias Hospital |
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Name:
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Maria Cruces Fernández Espartero, PhD/MD |
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Affiliation:
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General de Mostoles Hospital |
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Name:
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Pilar Fernández Dapica, PhD/MD |
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Address:
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Affiliation:
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University Hospital 12 de Octubre |
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Name:
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Rosario García de Vicuña, PhD/MD |
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Address:
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Affiliation:
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University Hospital de la Princesa |
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Name:
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Xavier Juanola Roura, PhD/MD |
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Address:
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Affiliation:
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Bellvitge Hospital |
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Name:
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Carlos Alberto Montilla Morales, PhD/MD |
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Address:
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Affiliation:
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Hospital Clinic of Salamanca |
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Name:
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Eduardo Collantes Estevez, PhD/ MD |
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Address:
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Affiliation:
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Reina Sofia Hospital |
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Name:
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Estefania Moreno Ruzafa, PhD/MD |
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Address:
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Affiliation:
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San Rafael Hospital |
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Name:
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Juan Mulero Mendoza, PhD/MD |
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Affiliation:
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Puerta de Hierro Hospital |
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Name:
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Jordi Gratacós, PhD/ MD |
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Affiliation:
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Parc Tauli Hospital |
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Name:
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Elia Brito Brito, PhD/MD |
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Affiliation:
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Ramon y Cajal Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients = 18 years.
2. Patients with diagnosis of AS (based on New York criteria) made = 6 months prior to
study start.
3. Patient with axial involvement.
4. Patients who have been treated with = 2 documented NSAID with proven anti-inflammatory
potency during at least 3 months at maximal recommended or tolerated doses prior the
visit 1.
5. Patients who demonstrate a Bath Ankylosing Spondylitis Disease Activity Index score of
= 4 (range 0-10).
Exclusion Criteria:
1. Patient that according to the investigator opinion is legally unable (i.e. mentally
incapable person), with psychiatric disorder precedent, active psychosis or emotional
problems at the moment to be enrolled in the study.
2. Patient who is participating in a clinical study with a drug or experimental device or
it was done within 4 weeks prior to the inform consent signature.
3. Patient with a recent history (since last 5 years) of abuse or dependence to opiates,
tranquilizer or drugs at the inform consent signature moment. Patient with a recent
history (since last 5 years) of alcoholism or drug addiction.
4. Patient with a history of neoplastic disease or malignant neoplasia = 5 years prior to
the inform consent signature, except basal cell or squamous cell cancer skin
adequately treated or uterine cancer insitu without recurrence prior to study entry
according to the investigator opinion. Patients with history of leukemia, lymphoma,
malignant melanoma or myeloproliferative disease cannot participate at the study.
5. Pregnancy, lactation or waiting to conceive a child
6. Patient with history of disorders, treatments or laboratory abnormality that can
interfere with the study results and study participation.
7. Patient cannot comply with the study procedures, study calendar. Patient with plan of
moving.
8. Patients awaiting the legal assessment of the degree of disability or the permanent
work disability
9. Patients unable to respond to questionnaires (difficulty understanding and / or
reading of questionnaires)
10. Any other warning that, in the investigator opinion, could discourage the inclusion of
the patient in the study.
11. Patient to be treated with other drug which can modulate the pain perception
12. Patients with AS associated disease (inflammatory bowel disease, psoriasis).
13. Patients with active peripheral articular involvement defined by presence of
peripheral arthritis.
14. Patient with predominant enthesitis or an enthesis that, according to investigator's
opinion, can confound the correct evaluation.
15. Presence of extra-articular manifestations.
16. Patients with fibromyalgia or other rheumatic disorders that could confound the
evaluation of efficacy
17. Patients with AS who received biologic therapy. Note: The use of approved nonstudy
antirheumatic therapy at a stable dose(methotrexate, sulfasalazine) for 3 months prior
to the study start will be allowed.
18. Patients with AS who received active treatment with etoricoxib
19. Hypersensitivity to the active substance or to any of the excipients
20. Active peptic ulceration or active gastro-intestinal bleeding
21. Patients with severe renal failure (creatinine clearance rate < 30 ml/min)
22. Congestive heart failure (NYHA II-IV)
23. Established ischaemic heart disease or cerebrovascular disease
24. Patients with severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score
=10).
25. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps,
angioneurotic oedema, urticaria, or allergic-type reactions after taking
acetylsalicylic acid or NSAIDs including cyclooxygenase-2 inhibitors
26. Patients with hypertension whose blood pressure is persistently elevated above
140/90mmHg and has not been adequately controlled
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Etoricoxib
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Primary Outcome(s)
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the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined
[Time Frame: the ASAS response were evaluated at week 2 and 4 and after 6 months treatment]
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Secondary ID(s)
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GRE-2009-01
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2009-017309-12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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