Low Back PainPhase 3NCT00141154

Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

A Phase 3 study testing Celecoxib and Loxoprofen in people with Low Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 38 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Celecoxib and Loxoprofen
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,234 participants
Where: 38 sitesJapan
Study dates: Oct 2004to not given
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
Patients who have had low back pain for at least two weeks

Who cannot join

Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain

Trial locations and contacts

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

Japan38 sites

Pfizer Investigational Site
Adachi-Ku, Tokyo
Pfizer Investigational Site
Bunkyou-ku, Tokyo
Pfizer Investigational Site
Chiba, 266-0031
Pfizer Investigational Site
Chitose, Hokkaido, 066-0026
Pfizer Investigational Site
Edogawa-ku, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Fukuoka, 810-0004
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Funabashi, Chiba, 273-0035
Pfizer Investigational Site
Funabashi-shi, Chiba
Pfizer Investigational Site
Hatogaya-shi, Saitama
Pfizer Investigational Site
Katougun, Hyōgo, 673-1462
Pfizer Investigational Site
Kobe, Hyōgo, 650 0004
Pfizer Investigational Site
Koito-ku, Tokyo
Pfizer Investigational Site
Kumagaya-shi, Saitama, 3600012
Pfizer Investigational Site
Kumagayashi, Saitama, 3600854
Pfizer Investigational Site
Matsudo-shi, Chiba
Pfizer Investigational Site
Meguro-Ku, Tokyo
Pfizer Investigational Site
Minamisaitama-gun, Saitama
Pfizer Investigational Site
Nakano-ku, Tokyo
Pfizer Investigational Site
Nerima-ku, Tokyo
Pfizer Investigational Site
Nishinomiya, Hyōgo, 662-0838
Pfizer Investigational Site
Ōta-ku, Tokyo, 145-0066
Pfizer Investigational Site
Ōta-ku, Tokyo
Pfizer Investigational Site
Sagamihara-shi, Kanagawa
Pfizer Investigational Site
Saitama-shi, Saitama
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Shibuya-ku, Tokyo
Pfizer Investigational Site
Shinagawa-ku, Tokyo, 140-0001
Pfizer Investigational Site
Shinjyuku-ku, Tokyo
Pfizer Investigational Site
Suginami-ku, Tokyo
Pfizer Investigational Site
Sumida-ku, Tokyo, 131-0043
Pfizer Investigational Site
tabashi City, Tokyo
Pfizer Investigational Site
Tokorozawa, Saitama
Pfizer Investigational Site
Tokyo, 140-0011
Pfizer Investigational Site
Toyoshima-ku, Tokyo
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain

To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.

Conditions: Low Back Pain
Being tested: Celecoxib, Placebo, Loxoprofen
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
PlaceboDrug
LoxoprofenDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient's pain assessment (VAS: Visual Analogue Scale)

Secondary outcomes (1)

Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004?

First posted1 Sep 2005 (estimated)
Study startOct 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00141154
Sponsor's protocol ID: A3191174
Status last verified: Mar 2021
First submitted: 30 Aug 2005
Last updated: 3 Mar 2021
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain
ClinicalTrials.gov ID: NCT00141154
Acronym / sponsor ID: A3191174
Conditions: Low Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,234 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2004
First posted: 1 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
Patients who have had low back pain for at least two weeks

Key exclusion criteria (1 listed)

Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Celecoxib	Drug	–
Placebo	Drug	–
Loxoprofen	Drug	–

Primary outcome

Patient's pain assessment (VAS: Visual Analogue Scale)

1 secondary outcome

Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

38 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celecoxib and Loxoprofen in people with Low Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 38 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient's pain assessment (VAS: Visual Analogue Scale). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00141154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.