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Acurox 5/ taken first

Phase 3

Pain | Small Molecules | Pain |Acura Pharmaceuticals Inc|Trials Updated: Oct 3, 2018

Acurox 5/ taken first target and mechanism

ModalitySmall Molecules

Also known as Acurox 5

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment435

FDA Designations

No designations recorded

Acurox 5/ taken first clinical trials

Acurox 5/ taken first · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00654069Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After BunionectomyPain
COMPLETED405 Analytics
PHASE3COMPLETED
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
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Study Endpoints

Primary Endpoints

SPID48
48 hours

Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0). SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5\*.5 + PID1\*.5 + PID2\*1 + PID3\*1 + PID4\*1 + PID6\*2 +PID12\*6 + PID18\*6 +PID24\*6 + PID30\*6 + PID36\*6 + PID42\*6 + PID48\*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).

Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
Effects assessed at 0.5 hours after dosing.

"Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORTablet
Acurox 5/30mgACTIVE_COMPARATOROxycodone HCl 5mg/Niacin 30mg tablet
Acurox 7.5/30PLACEBO_COMPARATOROxycodone HCl 7.5mg/Niacin 30mg tablet
Acurox 5/30mg taken firstACTIVE_COMPARATORoxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose
Oxycodone 5mg taken firstACTIVE_COMPARATORoxycodone HCl 5mg tablets; 8 tablets per dose

Interventions

NameTypeDescription
PlaceboDRUG2 tablets every 6 hours for 48 hours
Acurox 5/30 mgDRUG2 tablets every 6 hours for 48 hours
Acurox 7.5/30DRUG2 tablets every 6 hours for 48 hours
Acurox 5/30mg taken firstDRUGfollowed by oxycodone 5mg with 48 hour washout
Oxycodone 5mg taken firstDRUGfollowed by Acurox 5/30mg with 48 hour washout
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is male or female at least 18 years of age * For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * Patient is scheduled to have a bunionectomy * Patient must be willing to stay at ...

Countries:United States
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