Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.

A Six Week Double-Blind, Randomized, Multicenter Comparison Study of the Analgesic Effectiveness of Celecoxib 200 mg BID Compared to Tramadol Hydrochloride 50 mg QID in Subjects With Chronic Low Back Pain

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00290901

Enrollment

754

Registered

2006-02-13

Start date

2006-03-31

Completion date

Unknown

Last updated

2021-03-03

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

Conditions

Back Pain

Brief summary

This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.

Interventions

DRUGTramadol Hydrochloride 50mg

DRUGCelebrex 200mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* The subject presents with duration of chronic low back pain of \> 3 months requiring regular use of analgesics (\> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used.

Exclusion criteria

* The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)

Design outcomes

Primary

Measure	Time frame
To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6.	—

Secondary

Measure	Time frame
To compare the effects of treatment with celecoxib 200 mg BID and tramadol hydrochloride 50 mg QID on improvement in functionality and quality of life in subjects with chronic low back pain.	—

Countries

Puerto Rico, United States

Outcome results

None listed

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