Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640432

Enrollment

244

Registered

2008-03-21

Start date

2003-10-31

Completion date

2004-10-31

Last updated

2021-02-02

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

Conditions

Low Back Pain

Brief summary

To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain

Interventions

DRUGDiclofenac

75 mg oral capsule twice daily for 7 days

DRUGCelecoxib

400 mg oral capsule followed by 200 mg oral capsule with the evening meal (\>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Aged between 18 and 65 years * Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (\>50 mm in the VAS) * Acute low back pain onset \<72 hours prior to study inclusion and \>6 weeks after the last acute low back pain episode

Exclusion criteria

* Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain * Low back pain from major trauma or visceral disorder * Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug

Design outcomes

Primary

Measure	Time frame
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment	Day 3

Secondary

Measure	Time frame
Physical examination	Days 3 and 7
Pain relief score	Days 3 and 7
Vital signs	Days 3 and 7
Adverse events	Days 3 and 7
Subject's quality of life, as measured by the SF-36 Health Survey	Day 7
Categorical pain intensity score	Days 3 and 7
Subject's global assessment score	Days 3 and 7
Subject's functional ability, as measured by the Roland Morris Questionnaire about low back pain and disability	Day 7
Change from baseline in VAS pain intensity assessment	Day 7

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026