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tramadol; celecoxib

Phase 3

Chronic Pain | Small molecule | Pain |Bausch Health Companies Inc.|Last Updated: Jun 21, 2012

Target and mechanism

ModalitySmall molecule

Also known as tramadol HCl ER; celecoxib

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,000

FDA Designations

No designations recorded

Clinical trial landscape

tramadol; celecoxib · 1 trial · 1 indication

Phase 3 1
NCT00348452A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA)Chronic Pain
COMPLETED1,000 Analytics
PHASE3COMPLETED
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA)
Chronic Pain
NCT003484521,000
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Study Endpoints

Primary Endpoints

The primary outcome is the change from baseline to week 12 in the WOMAC OA Index pain and physical function subscale scores and the patient global assessment of disease activity.

Secondary Endpoints

The secondary outcomes include: change from baseline in the daily arthritis pain intensity scores from patient diaries, WOMAC OA stiffness subscale scores, OA pain intensity VAS for index and non-index joints, and Chronic Pain Sleep Inventory scale
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
tramadol HCl ER; celecoxibDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with American College of Rheumatology (ACR) Functional Class I-III OA of the knee or hip; * Patients with involvement of knee or hip joint that warrants treatment with COX-2 selective inhibitors, NSAIDs, acetaminophen, or opioid analgesics for at least 75 of the 90 da...

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Competitive Landscape -Chronic Pain 49 trials

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY2PHASE3Retatrutide
Boston Scientific CorporationBSX5N/AUndisclosed
Creative Medical Technology Holdings, Inc.CELZ1PHASE1CELZ-201-DDT
Zimmer Biomet Holdings, Inc.ZBH6N/AUndisclosed
Hinge Health, Inc. Class AHNGE2N/AUndisclosed
Abbott LaboratoriesABT2N/AUndisclosed
SI-BONE, Inc.SIBN1 - Undisclosed
Axogen, Inc.AXGN1N/AUndisclosed
United Therapeutics CorporationUTHR1PHASE1Metformin
Precision BioSciences, Inc.DTIL1PHASE1MC-1-50
Galapagos NV Sponsored ADRGLPG1 - Undisclosed
Medtronic PlcMDT1 - Undisclosed
Forte Biosciences Inc.FBRX2N/AUndisclosed
Teleflex IncorporatedTFX1 - Undisclosed
Collegium Pharmaceutical, Inc.COLL1N/AUndisclosed
Sage BionetworksSAGE1 - Undisclosed
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