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Hydrocodone/Acetaminophen

Phase 2

Pain | Small molecule | Pain |Abbott Laboratories|Last Updated: Jan 19, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Hydrocodone/Acetaminophen · 1 trial · 1 indication

Phase 2 1
NCT00404183A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With OsteoarthritisPain
COMPLETED120 Analytics
PHASE2COMPLETED
A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis
Pain
NCT00404183120
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Study Endpoints

Primary Endpoints

Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
4 weeks

Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)

Secondary Endpoints

WOMAC Osteoarthritis Index, SF36
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
hydrocodone/acetaminophen extended releaseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Extended-Release Hydrocodone/AcetaminophenDRUG2 tablets BID
PlaceboDRUG2 tablets BID
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Eligibility Criteria

Age Range21 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males or females ages 21 to 75 * Has osteoarthritis of the hip or knee * Requires therapeutic doses of medications for osteoarthritis * If female, must be of non-childbearing potential or practicing birth control * Has sufficient pain to justify the use of round-the-clock opio...

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Frequently asked questions about Hydrocodone/Acetaminophen

What is Hydrocodone/Acetaminophen used for?

Hydrocodone/Acetaminophen is used for the treatment of pain. It is being studied in patients with osteoarthritis, a condition that causes joint pain. The drug is a small molecule combination therapy being developed by Abbott Laboratories.

How does Hydrocodone/Acetaminophen work?

Hydrocodone/Acetaminophen combines an opioid analgesic with a non-opioid analgesic. Hydrocodone works by binding to opioid receptors in the brain and spinal cord to reduce pain perception, while acetaminophen works by inhibiting prostaglandin synthesis in the central nervous system to relieve pain and reduce fever.

Who makes Hydrocodone/Acetaminophen?

Hydrocodone/Acetaminophen is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The company is conducting clinical trials to evaluate the drug's safety and efficacy for pain management.

What phase is Hydrocodone/Acetaminophen in?

Hydrocodone/Acetaminophen is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for its analgesic efficacy and safety in patients with osteoarthritis-related pain.

What clinical trials is Hydrocodone/Acetaminophen in?

Hydrocodone/Acetaminophen has one completed Phase 2 clinical trial registered under NCT00404183. This randomized, double-blind, placebo-controlled study enrolled 120 participants to compare the analgesic efficacy and safety of extended release Hydrocodone/Acetaminophen versus placebo in subjects with osteoarthritis.