A Double-Blind, Parallel-Group, 4-week Trial to Assess the Efficacy and Safety of Etoricoxib 60mg and Diclofenac 150mg in Patients with Chronic Low Back Pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000487-27-SE

Enrollment

400

Registered

2004-07-07

Start date

2004-08-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain MedDRA version: 7.0 Level: LLT Classification code 10008837

Interventions

Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 Pharmaceutical Form: Tablet INN or Proposed INN: Etoricoxib CAS Number: 2024-9-33-4 Current Sponsor code: MK-0663 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patient is man or woman aged >/= 18 years 2) patient has low back pain that satisfies Quebec Task Force on Spinal Disorders Class 1 or 2 3) Patient has had back pain for a minimum of the previous 3 months AND for the majority of days in the last month 4) patient has been using either NSAIDs or paracetamol, on a regular basis for at least 30 days prior to Visit 1 for the treatment of low back pain. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Patient has low back pain due to secondary causes such as malignancy, inflammatory disease, osteoporosis of the lumbar spine, ochronosis, vertebral fracture, etc 2) Patient experiences radicular/myelopathic pains 3) patient has had surgery for low back pain within the past six months 4) patient is involved in an active civil law suit or workman's compensation claim pertaining to his/her low back pain. 5) Patient has had clinical depression within the last 1 year or is on active treatment for depression.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) to evaluate the efficacy of etoricoxib 60mg for the treatment of chronic low back pain compared to diclofenac 150mg as assessed by the Low Back Pain Intensity Scale (0- to 100-mm VAS) over four weeks of treatment 2) to investigate the overall safety and tolerability of etoricoxib 60mg once daily during a four-week period;Primary end point(s): The primary efficacy endpoint is: time-weighted average change from baseline in Low Back Pain Intensity score (0- to 100-mm VAS) ove the total 4-week treatment period;Secondary Objective: 1)to compare the effects of etoricoxib 60mg and diclofenac 150mg treatment on chronic low back pain via responses on the Roland and Morris Disability Questionnaire 2) to compare the efficacy of etoricoxib 60mg daily and diclofenac 150mg daily during a four week treatment period as assessed by the Patient Global Assessment of Response to Therapy (PGART) 3) to compare the early efficacy of etoricoxib 60mg daily and diclofenac 150mg daily as assessed by the PGART and Low Back Pain Intensity Scale 4 hours after the first dose in the morning of days 1,2, and 3.	—

Measure

Time frame

Main Objective: 1) to evaluate the efficacy of etoricoxib 60mg for the treatment of chronic low back pain compared to diclofenac 150mg as assessed by the Low Back Pain Intensity Scale (0- to 100-mm VAS) over four weeks of treatment 2) to investigate the overall safety and tolerability of etoricoxib 60mg once daily during a four-week period;Primary end point(s): The primary efficacy endpoint is: time-weighted average change from baseline in Low Back Pain Intensity score (0- to 100-mm VAS) ove the total 4-week treatment period;Secondary Objective: 1)to compare the effects of etoricoxib 60mg and diclofenac 150mg treatment on chronic low back pain via responses on the Roland and Morris Disability Questionnaire 2) to compare the efficacy of etoricoxib 60mg daily and diclofenac 150mg daily during a four week treatment period as assessed by the Patient Global Assessment of Response to Therapy (PGART) 3) to compare the early efficacy of etoricoxib 60mg daily and diclofenac 150mg daily as assessed by the PGART and Low Back Pain Intensity Scale 4 hours after the first dose in the morning of days 1,2, and 3.

—

Countries

Hungary, Italy, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026