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PainPhase 2NCT01038609

Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

A Phase 2 study testing Hydrocodone/Acetaminophen Extended Release, Acetaminophen and Morphine Extended Release in people with Pain, run by AbbVie (prior sponsor, Abbott) at 4 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 moderate to severe pain following primary unilateral first metatarsal 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, Acetaminophen and Morphine Extended Release
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
4 sitesUnited States
Study dates
Dec 2009to May 2010
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 surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures.

Who cannot join

  • Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures
  • Allergic reaction to study medications
  • Pregnant or breastfeeding females
  • Clinically significant lab abnormalities at screening
  • Positive hepatitis testing at screening
  • Clinically significant or uncontrolled medical disorders or illness at screening
Show all 12Show fewer
  • Active malignancy or chemotherapy
  • Any history of drug or alcohol abuse/addiction
  • Known or suspected history of human immunodeficiency virus (HIV); requires treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or butyrophenones
  • History of major depressive episode or major psychiatric disorder
  • Current systemic corticosteroid therapy
  • Inability to refrain from smoking during or alcohol during stay at investigative site

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Site Reference ID/Investigator# 26302

    Austin, Texas, 78705

  • Site Reference ID/Investigator# 26223

    Peoria, Arizona, 85381

  • Site Reference ID/Investigator# 26303

    San Marcos, Texas, 78666

  • Site Reference ID/Investigator# 26304

    West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen to Placebo in Subjects With Acute Pain Following Bunionectomy

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal 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 5 treatment arms. In order to maintain the single-blind nature of the study, all participants were dosed with study drug (active and/or placebo) every 6 hours.

Conditions
Pain
Being tested
Hydrocodone/Acetaminophen Extended Release, Acetaminophen, Morphine Extended Release, Placebo
Keywords
Postoperative Pain
Medical subject headings
Pain, Pain, Postoperative

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

  • AcetaminophenDrug

    Also called Tylenol

  • Morphine Extended ReleaseDrug

    Also called Kadian

  • PlaceboDrug

Study groups in NCT01038609
Study groupRoleWhat they receive
PlaceboPlacebo comparator1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Receives: Drug: Placebo
AcetaminophenActive comparator1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
Receives: Drug: Acetaminophen
Morphine Extended ReleaseActive comparator1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Receives: Drug: Morphine Extended Release
Morphine Extended Release / AcetaminophenActive comparator1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
Receives: Drug: Acetaminophen; Drug: Morphine Extended Release
Hydrocodone/Acetaminophen Extended ReleaseExperimental1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Receives: Drug: Hydrocodone/Acetaminophen Extended Release

What is being measured

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

  1. Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue 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 48 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 48 hours following first study drug administration

Secondary outcomes (6)

  1. 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 48 hours following first study drug administration

  2. Participant's Global Assessment of Study Drug

    The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor.

    Measured: From time of first study drug administration to 48 hours following first study drug administration

  3. 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

  4. Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.

    Measured: 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).

  5. Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria

    Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate <10 respirations per minute (rpm) (low) or >24 rpm (high).

    Measured: At specified intervals from Screening through 7 days after first dose of study drug

  6. Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria

    Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L.

    Measured: At specified intervals from Screening through 7 days after first dose of study drug

Timeline

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

  1. First posted24 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

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
Single blind
Who is masked
Participant
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01038609
Sponsor's protocol ID
M12-058
Status last verified
Mar 2014
First submitted
22 Dec 2009
Last updated
8 Apr 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydrocodone/Acetaminophen Extended Release, Acetaminophen and Morphine Extended Release in people with Pain, run by AbbVie (prior sponsor, Abbott) at 4 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 12 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 4 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 Analogue Scale (VAS) (time frame: From time of first study drug administration to 48 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 NCT01038609.

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.

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