NCT00404222

Brief Summary

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

3 months

First QC Date

November 26, 2006

Last Update Submit

July 22, 2011

Conditions

Pain

Keywords

Acute Pain following Bunionectomy

Outcome Measures

Primary Outcomes (2)

  • The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.

    12 hours

  • Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)

    12 hours

Secondary Outcomes (5)

  • Time-interval weighted sum of pain relief (TOTPAR)

    12 hours

  • Time-interval weighted sum of pain relief and pain intensity difference (SPRID)

    12 hours

  • Time to first noticeable pain relief (i.e., onset of pain relief)

    12 hours

  • Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)

    12 hours

  • Proportion of subjects experiencing meaningful pain relief after dosing

    12 hours

Study Arms (3)

hydrocodone / acetaminophen extended release

EXPERIMENTAL
Drug: Hydrocodone/Acetaminophen Extended-Release

Hydrocodone/Acetaminophen Immediate Release (Norco ®)

ACTIVE COMPARATOR
Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Hydrocodone/Acetaminophen Extended-ReleaseDRUG

2 tablets x 1

Also known as: hydrocodone / acetaminophen extended release
hydrocodone / acetaminophen extended release
Hydrocodone/Acetaminophen Immediate Release (NORCO®)DRUG

1 tablet q 4 hours x 3

Hydrocodone/Acetaminophen Immediate Release (Norco ®)
PlaceboDRUG

q 4 hours x 3

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ages 18 to 65
  • Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
  • Must meet specific pain intensity criteria on the morning after surgery
  • Willing to remain at the study center 2 days following surgery
  • If female, must be of non-child bearing potential or practicing birth control

You may not qualify if:

  • Is allergic to or has a serious reaction to hydrocodone, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
  • Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Has a history of or currently has any active seizure disorder
  • Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
  • Has been diagnosed with cancer within the past 3 years
  • Requires treatment with certain drugs for depression or psychiatric disorders
  • Has specific clinically significant illnesses or laboratory abnormalities
  • Received corticosteroid treatment or any investigational drug within a specific timeframe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

HydrocodoneAcetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rita Jain, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 26, 2006

First Posted

November 28, 2006

Study Start

November 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

July 25, 2011

Record last verified: 2011-07