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Bupivacaine TTS

Phase 2

Chronic Low Back Pain | Small molecule | Pain |DURECT Corporation|Last Updated: Jun 15, 2022

Target and mechanism

ModalitySmall molecule

Also known as Bupivacaine TTS (Bupivacaine Patch)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment263

FDA Designations

No designations recorded

Clinical trial landscape

Bupivacaine TTS · 1 trial · 1 indication

Phase 2 1
NCT01096966Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back PainChronic Low Back Pain
COMPLETED263 Analytics
PHASE2COMPLETED
Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
Chronic Low Back Pain
NCT01096966263
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Study Endpoints

Primary Endpoints

Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
baseline to 12 weeks after baseline

Secondary Endpoints

Subjects achieving 20% pain relief at 12 weeks compared to baseline
baseline to 12 weeks after baseline
Subjects 'much improved' or 'very much improved' at 12 weeks
12 weeks after baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bupivacaine TTSEXPERIMENTAL -
Placebo patchPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Bupivacaine TTS (Bupivacaine Patch)DRUGContains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks.
Placebo patchDRUGIdentical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Diagnosis of chronic low back pain for more than 3 months 2. If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for ...

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

Top 20 of 25 competitors

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Novartis AG Sponsored ADRNVS4PHASE3zigakibart
Novo Nordisk A/S Sponsored ADR Class BNVO3PHASE3DCR-PHXC
Amgen Inc.AMGN1PHASE3Etelcalcetide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE3Mezagitamab
ProKidney Corp. Class APROK3PHASE3Renal Autologous Cell Therapy
Humacyte, Inc.HUMA1PHASE3Acellular Tissue Engineered Vessel
Fresenius Medical Care AG Sponsored ADRFMS6PHASE2Difelikefalin
DexCom, Inc.DXCM1PHASE3Sotagliflozin
GSK plc Sponsored ADRGSK1PHASE1GSK4771261
Regeneron Pharmaceuticals, Inc.REGN2PHASE1Vonsetamig
Merck & Co., Inc.MRK1PHASE1MK-2828
United Therapeutics CorporationUTHR2PHASE110 GE Xenokidney
Pfizer Inc.PFE1PHASE1PF-07328948
OPKO Health, Inc.OPK1PHASE2CTAP101
Medtronic PlcMDT2 - Undisclosed
Incyte CorporationINCY1PHASE1INCB123667
Merit Medical Systems, Inc.MMSI1 - Undisclosed
Sanofi SA Sponsored ADRSNY1 - Undisclosed
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