NCT00402792

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 compared to placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3 pain

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

4 months

First QC Date

November 20, 2006

Last Update Submit

January 24, 2011

Conditions

Pain

Keywords

Acute pain following bunionectomy surgery

Outcome Measures

Primary Outcomes (1)

  • Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration.

    Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)

    12 hours

Secondary Outcomes (6)

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

    12 hours

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

    12 hours

  • Perceptible pain relief

    12 hours

  • Meaningful pain relief

    12 hours

  • Pain relief (PR)

    12 hours

  • +1 more secondary outcomes

Study Arms (3)

Arm 1: hydrocodone / acetaminophen extended release

EXPERIMENTAL
Drug: Hydrocodone/Acetaminophen Extended-Release

Arm 2: hydrocodone / acetaminophen extended release

EXPERIMENTAL
Drug: Hydrocodone/Acetaminophen Extended Release

Arm 3: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Hydrocodone/Acetaminophen Extended-ReleaseDRUG

1 tablet q 12 hours

Also known as: ABT-712, hydrocodone / acetaminophen extended release
Arm 1: hydrocodone / acetaminophen extended release
Hydrocodone/Acetaminophen Extended ReleaseDRUG

2 tablets q 12 hours

Also known as: ABT-712, hydrocodone / acetaminophen extended release
Arm 2: hydrocodone / acetaminophen extended release
PlaceboDRUG

2 tablets q 12 hours

Arm 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
  • Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
  • Meet specific pain intensity criteria on the morning after surgery
  • Willing to be confined for 4 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, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
  • Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract
  • Has specific active or uncontrolled seizure disorders
  • Has been diagnosed with certain cancers within the past 5 years
  • Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression
  • Has specific clinically significant illnesses or laboratory abnormalities
  • Has received corticosteroid treatment or any investigational drug within a specific timeframe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Site Ref # / Investigator 2589

Austin, Texas, 78705, United States

Location

Site Ref # / Investigator 2587

Houston, Texas, 77081, United States

Location

Site Ref # / Investigator 2586

San Antonio, Texas, 78229, United States

Location

Site Ref # / Investigator 2588

San Marcos, Texas, 78666, United States

Location

Site Ref # / Investigator 2585

Salt Lake City, Utah, 84094, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Hydrocodone

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 Compounds

Study Officials

  • Rita Jain, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

December 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

January 25, 2011

Record last verified: 2011-01

Locations

US(5)