Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)

NCT01067430 | Withdrawn Phase 4

• 1 other identifier: IISP 35166
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with early morning pain and stiffness.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Etoricoxib; Diclofenac; Pain; Stiffness

Outcome Measures

Primary Outcomes (1)

• To explore the effect of Etoricoxib compared to Diclofenac on physical activity in RA subjects with Early morning pain and stiffness.

  Subjects will be asked to complete a visual analogue scale to record pain and stiffness and activity will be recorded with the Numact devise

  After 14 days of treatment

Study Arms (2)

Etoricoxib 90 mg

ACTIVE COMPARATOR

Subject will take Etoricoxib 90 mg for 14 days

Drug: Etoricoxib

Diclofenac

ACTIVE COMPARATOR

Film coated tablet 50 mgs given three times a day for 14 days

Drug: Diclofenac

Interventions

Etoricoxib DRUG

Film coated tablet, 90 mg taken once a day for 14 days

Also known as: Arcoxia

Etoricoxib 90 mg

Diclofenac DRUG

Enteric coated tablet 50 mg given three times a day for 14 days

Also known as: Voltarol

Diclofenac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 18 years and over.
• Subjects who are NSAID tolerant.
• Subjects with a clinical diagnosis of rheumatoid arthritis.
• Subjects who are willing to complete QOL questionnaires.
• Written informed consent

You may not qualify if:

• Co-occurrence of other disabling conditions in addition to rheumatoid arthritis likely to warrant the persistent use of escape analgesia.
• Subjects who have received an intra-articular or muscular steroid injection within 3 months of study entry or in whom such treatment is planned within the study period.
• Subjects scheduled for elective surgery of the disease site or any other elective major surgery which would fall within the study period.
• Severe respiratory impairment.
• Clinically significant hepatic or renal dysfunction, subjects whose LFTs and serum creatinine is outside normal recognized limits.
• Subjects with convulsive disorders, head injury, shock, reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure.
• Subjects with a known allergy or hypersensitivity to NSAIDs.
• Subjects with unstable gastro-intestinal complications or disease.
• Subjects who currently abuse alcohol or drugs, or have a recent history of alcohol or drug abuse, or who in the Investigator's opinion, have previously demonstrated drug-seeking behaviour.
• Subjects who are currently participating in another clinical research study involving a new chemical entity or who have participated in a clinical study within the previous 30 days.

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust: lead

Study Sites (1)

Northumbria Healthcare NHS Foundation Trust

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Pain

Interventions

Etoricoxib; Diclofenac

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• David J Walker, MD

  Northumbria Healthcare NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

GB (1)