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Oxycodone DETERx

Phase 3

Chronic Low Back Pain | Small molecule | Pain |Collegium Pharmaceutical, Inc.|Last Updated: Oct 19, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment740

FDA Designations

No designations recorded

Clinical trial landscape

Oxycodone DETERx · 1 trial · 1 indication

Phase 3 1
NCT01685684Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)Chronic Low Back Pain
COMPLETED740 Analytics
PHASE3COMPLETED
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
Chronic Low Back Pain
NCT01685684740
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Study Endpoints

Primary Endpoints

Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase
Randomized Baseline through Week 12

The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Secondary Endpoints

Time-to-exit From the Study for All Causes
Randomization Baseline through Week 12
Percent Reduction in Pain Intensity for Responders
Screening Baseline through Week 12
Weekly Changes in Pain Intensity
Randomization Baseline and weekly through Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oxycodone DETERxEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Oxycodone DETERxDRUG40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
PlaceboDRUGPlacebo, divided into 2 doses, q12h
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: * Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent. * Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening. * Must qualify for ATC opioid therapy for treatment of CLBP. * Must be classified as non...

Countries:United States
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Competitive Landscape -Chronic Kidney Disease 85 trials (matched to "Chronic Low Back Pain")

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United Therapeutics CorporationUTHR2PHASE110 GE Xenokidney
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Medtronic PlcMDT2 - Undisclosed
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