Effect of Etoricoxib to Treat Chronic Low Back Pain (0663... | NCT00393211

Studies
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)

NCT00393211

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Feb 18, 2022Actual

Enrollment

319Actual

Phase

Phase 3

Conditions

Recurrent Low Back Pain

Interventions

MK0663, Etoricoxib / Duration of Treatment : 12 Weeks
Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006_547

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2000

Primary Completion Date

Nov 2000Actual

Completion Date

Nov 2000Actual

First Submitted Date

Oct 26, 2006

First Submission Date that Met QC Criteria

Oct 26, 2006

First Posted Date

Oct 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2022

Last Update Posted Date

Feb 18, 2022Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

319Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK0663, Etoricoxib / Duration of Treatment : 12 Weeks	Drug
Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo

Secondary Outcomes

Measure	Description	Time Frame
Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low back pain for previous 3 months and majority of days in last month
Regular use of acetaminophen or NSAID to treat low back pain in past month
Judged to be in otherwise good health

Exclusion Criteria:

Low back pain that is due to secondary causes
Radicular/myelopathic pain
Surgery for low back pain within the past 6 months
Active lawsuit or claim pertaining to their low back pain
Disease that may confound the results of the study or pose risk to the patients
Corticosteroid use in past month
Previous participation in an MK0663 study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14622687	Background	Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, Geba GP; Etoricoxib Protocol 042 Study Group. Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial. J Pain. 2003 Aug;4(6):307-15. doi: 10.1016/s1526-5900(03)00633-3.
14996519

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D000077613	Etoricoxib
D000081206	Duration of Therapy

ID	Term
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines