PainPhase 2NCT01333722

Acute Pain Study Following Bunionectomy

A Phase 2 study testing Hydrocodone/Acetaminophen Extended Release in people with Pain, run by AbbVie (prior sponsor, Abbott) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain
What is being tested?: Hydrocodone/Acetaminophen Extended Release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 3 sitesUnited States
Study dates: Apr 2011to Jun 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy

Who cannot join

Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
Drug allergies to hydrocodone, acetaminophen
Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Site Reference ID/Investigator# 51602
Austin, Texas, 78705
Site Reference ID/Investigator# 51464
Pasadena, California, 91105
Site Reference ID/Investigator# 51344
Salt Lake City, Utah, 84117

Other trials in United States

About this study

Official title: A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy

Read the detailed description

The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Conditions: Pain
Being tested: Hydrocodone/Acetaminophen Extended Release, Placebo
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydrocodone/Acetaminophen Extended ReleaseDrug
Also called ABT-712
PlaceboDrug
Placebo tablet

Study groups in NCT01333722
Study group	Role	What they receive
Placebo	Placebo comparator	placebo, 1 oral tablet every 12 hours Receives: Drug: Placebo
Hydrocodone/Acetaminophen Extended Release	Experimental	hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours Receives: Drug: Hydrocodone/Acetaminophen Extended Release

What is being measured

The primary outcome is the main question the study is designed to answer.

Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Measured: From time of first study drug administration to 12 hours following first study drug administration

Secondary outcomes (3)

TOTPAR (Total Pain Relief)
TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Measured: From time of first study drug administration to 12 hours following first study drug administration
SPRID (Pain Relief and Pain Intensity Difference)
SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: "My pain at this time is…" with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Measured: From time of first study drug administration to 12 hours following first study drug administration
Time to Perceptible and Meaningful Pain Relief
The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.
Measured: From time of first study drug administration to 12 hours following first study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Jun 2011

First posted12 Apr 2011 (estimated)
Study startApr 2011
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01333722
Sponsor's protocol ID: M12-169
Status last verified: Mar 2014
First submitted: 11 Apr 2011
Last updated: 8 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy
ClinicalTrials.gov ID: NCT01333722
Acronym / sponsor ID: M12-169
Conditions: Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 12 Apr 2011 (estimated)
Results: Posted 7 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placeboplacebo, 1 oral tablet every 12 hours
Hydrocodone/Acetaminophen Extended Release	Experimental	Drug: Hydrocodone/Acetaminophen Extended Releasehydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy

Key exclusion criteria (3 listed)

Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
Drug allergies to hydrocodone, acetaminophen
Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrocodone/Acetaminophen Extended ReleaseAlso: ABT-712	Drug	Hydrocodone/Acetaminophen Extended Release
PlaceboPlacebo tablet	Drug	Placebo

Primary outcome

Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Time frame: From time of first study drug administration to 12 hours following first study drug administration
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.

3 secondary outcomes

TOTPAR (Total Pain Relief)
Time frame: From time of first study drug administration to 12 hours following first study drug administration
SPRID (Pain Relief and Pain Intensity Difference)
Time frame: From time of first study drug administration to 12 hours following first study drug administration
Time to Perceptible and Meaningful Pain Relief
Time frame: From time of first study drug administration to 12 hours following first study drug administration

Results and safety

Results posted to the registry on 7 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hydrocodone/Acetaminophen Extended Release	51	51
Placebo	49	46

Primary outcome: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)

Time frame: From time of first study drug administration to 12 hours following first study drug administration. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Hydrocodone/Acetaminophen Extended Release n = 51	Placebo n = 49
Value	259.0 (37.52)	39.4 (38.10)

Population analysed: All randomized participants who received at least 1 dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hydrocodone/Acetaminophen Extended Release	0 of 51 (0%)	28 of 51 (54.9%)	Not reported
Placebo	0 of 49 (0%)	14 of 49 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pedro Quintana Diez, MD study director

AbbVie

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydrocodone/Acetaminophen Extended Release in people with Pain, run by AbbVie (prior sponsor, Abbott) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) (time frame: From time of first study drug administration to 12 hours following first study drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01333722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.