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Tramadol

Phase 4FDA approved

Chronic Pain | Small molecule | Pain |Bausch Health Companies Inc.|Trials Updated: Aug 27, 2012

Tramadol development status

FDA approval on record Sep 8, 2005
Approval holderValeant Pharms
ApplicationNDA021692
Highest phase Phase 4 run by The Cleveland Clinic (NCT06373978)
Phase scored for BHCPhase 3
Registered trials 12 across 8 sponsors since Sep 2005

Tramadol target and mechanism

Molecular targetOPRM1
Target classAgonist
ModalitySmall molecule

Also known as Tramadol HCl ER, tramadol ER

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment2,495

FDA Designations

No designations recorded

Tramadol clinical trials

Tramadol · 4 trials · 1 indication

Phase 3 4
NCT00325858A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or HipChronic Pain
COMPLETED1,000 Analytics
NCT00347724A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back PainChronic Pain
COMPLETED600 Analytics
NCT00348010A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the KneeChronic Pain
COMPLETED245 Analytics
NCT00347685A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.Chronic Pain
COMPLETED650 Analytics
PHASE3COMPLETED
A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip
Chronic PainUnlock trial analytics
PHASE3COMPLETED
A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain
Chronic PainUnlock trial analytics
PHASE3COMPLETED
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the Knee
Chronic PainUnlock trial analytics
PHASE3COMPLETED
A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.
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.
Patient's pain intensity score since the previous visit,using a visual analog scale(VAS) where 0 mm = no pain and 100 mm = extreme pain.
The primary efficacy outcome is the change in arthritis pain intensity score
averages over the 12 weeks of the study.
The primary outcomes are analyses of adverse events (incidence, frequency,
severity, attribution, adverse events causing withdrawal from study)

Secondary Endpoints

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

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Tramadol HCl ERDRUG -
tramadol ERDRUG -
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites1

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

Countries:United States
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Competitive Landscape -Chronic Pain 78 trials

Frequently asked questions about Tramadol

What is Tramadol used for?

Tramadol is used for the treatment of chronic pain. It is being developed by Bausch Health Companies Inc. under the ticker BHC. The clinical program has focused on chronic pain conditions, including osteoarthritis of the knee and hip as well as chronic low back pain.

How does Tramadol work?

Tramadol acts as an agonist at OPRM1, the mu-opioid receptor. By binding to and activating this receptor, it interferes with pain signaling. This mechanism places Tramadol in the agonist class of small molecule pain therapies.

Who makes Tramadol?

Tramadol is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company has sponsored the clinical trial program evaluating extended-release formulations of the drug for chronic pain.

What phase is Tramadol in?

Tramadol is in Phase 3 clinical development for chronic pain. It is an investigational therapy and has not been approved by the FDA for this use. The Phase 3 program includes completed trials, with no active trials currently listed.

What clinical trials is Tramadol in?

Tramadol has been studied in four completed Phase 3 trials: NCT00348010 in knee osteoarthritis, NCT00347724 in chronic low back pain, NCT00347685 as a one-year open-label safety study, and NCT00325858 comparing multiple dose strengths in knee and hip osteoarthritis. Total enrollment across these trials was 2,495 participants.

Is Tramadol the same as Tramadol HCl ER or tramadol ER?

Yes, Tramadol HCl ER and tramadol ER are alternative names for the extended-release formulation of Tramadol. These names refer to the same active drug, tramadol hydrochloride, in an extended-release dosage form developed for chronic pain.