NCT00141154

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,234

participants targeted

Target at P75+ for phase_3 low-back-pain

Geographic Reach
1 country

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

First QC Date

August 30, 2005

Last Update Submit

March 1, 2021

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

CelecoxibDRUG
PlaceboDRUG
LoxoprofenDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Pfizer Investigational Site

Funabashi, Chiba, 273-0035, Japan

Location

Pfizer Investigational Site

Funabashi-shi, Chiba, Japan

Location

Pfizer Investigational Site

Matsudo-shi, Chiba, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Chitose, Hokkaido, 066-0026, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Katougun, Hyōgo, 673-1462, Japan

Location

Pfizer Investigational Site

Kobe, Hyōgo, 650 0004, Japan

Location

Pfizer Investigational Site

Nishinomiya, Hyōgo, 662-0838, Japan

Location

Pfizer Investigational Site

Sagamihara-shi, Kanagawa, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Hatogaya-shi, Saitama, Japan

Location

Pfizer Investigational Site

Kumagaya-shi, Saitama, 3600012, Japan

Location

Pfizer Investigational Site

Kumagayashi, Saitama, 3600854, Japan

Location

Pfizer Investigational Site

Minamisaitama-gun, Saitama, Japan

Location

Pfizer Investigational Site

Saitama-shi, Saitama, Japan

Location

Pfizer Investigational Site

Tokorozawa, Saitama, Japan

Location

Pfizer Investigational Site

Adachi-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Bunkyou-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Itabashi-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Koito-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Meguro-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Nakano-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Nerima-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Ōta-ku, Tokyo, 145-0066, Japan

Location

Pfizer Investigational Site

Ōta-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shibuya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinagawa-ku, Tokyo, 140-0001, Japan

Location

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Suginami-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Sumida-ku, Tokyo, 131-0043, Japan

Location

Pfizer Investigational Site

Toyoshima-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Chiba, 266-0031, Japan

Location

Pfizer Investigational Site

Fukuoka, 810-0004, Japan

Location

Pfizer Investigational Site

Fukuoka, Japan

Location

Pfizer Investigational Site

Tokyo, 140-0011, Japan

Location

Related Links

MeSH Terms

Conditions

Low Back Pain

Interventions

Celecoxibloxoprofen

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

October 1, 2004

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

JP(38)