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tramadol; celecoxib

Phase 3

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

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

tramadol; celecoxib clinical trials

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 PainUnlock trial analytics

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 78 trials

Frequently asked questions about tramadol; celecoxib

What is tramadol; celecoxib?

Tramadol; celecoxib refers to a development program combining extended release tramadol HCl with celecoxib for the treatment of chronic pain. Bausch Health Companies Inc. (ticker BHC) is developing this combination, which is in Phase 3 clinical development. Both components are small molecule agents.

What is tramadol; celecoxib used for?

Tramadol; celecoxib is being developed for chronic pain. The Phase 3 trial for this program evaluated extended release tramadol HCl at 100 mg, 200 mg and 300 mg doses for moderate to severe pain due to osteoarthritis. The program has not been approved and remains investigational.

Who makes tramadol; celecoxib?

Bausch Health Companies Inc., which trades under the ticker BHC, is the developer of the tramadol; celecoxib program. The company is advancing this combination for chronic pain through Phase 3 clinical development.

What phase is tramadol; celecoxib in?

Tramadol; celecoxib is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational and has not received FDA approval for any indication.

What clinical trials is tramadol; celecoxib in?

The tramadol; celecoxib program includes the completed Phase 3 trial NCT00348452, titled 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. It enrolled 1,000 participants aged 18 years and older.

Is tramadol; celecoxib the same as tramadol HCl ER?

Tramadol; celecoxib is also known as tramadol HCl ER and celecoxib. The extended release tramadol HCl component was studied at 100 mg, 200 mg and 300 mg doses in the Phase 3 osteoarthritis pain trial NCT00348452.