PainPhase 3NCT00564486

Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain

A Phase 3 study testing IV Acetaminophen in people with Pain, run by Mallinckrodt at 17 sites in United States.

Completed

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

Trial summary

This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein [IV]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: IV Acetaminophen
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 244 participants
Where: 17 sitesUnited States
Study dates: Nov 2007to Sep 2008
Phase: Phase 3
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provide written Informed Consent prior to participation in the Study
Is scheduled to undergo abdominal laparoscopic surgery under general anesthesia (laparoscopic bariatric procedures, including gastric bypass or gastric banding, laparoscopic exploratory procedures in which no visceral dissection is performed, and laparoscopic procedures with minimal visceral dissection, such as laparoscopic sterilization,are excluded)
If Subject is a female of childbearing potential, have a negative pregnancy test within 21 days of surgery
Be at least 18, but not more than 80 years of age
Have a Body Mass Index (BMI) ≥ 19 and ≤ 40 lb/in2
Have an American Society of Anesthesiologist (ASA) risk class of I, II, or III
Have the ability to read and understand the Study procedures and the use of the pain scales and have the ability to communicate meaningfully with the Study Investigator and staff
Be free of other physical, mental, or medical conditions which, in the opinion of the Investigator, makes Study participation inadvisable

Who cannot join

Used opioids or tramadol daily for greater than 7 days prior to Study Medication administration (Subjects who, in the Investigator's opinion have or are developing opioid tolerance are to be excluded)
Has been treated with Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal, Skullcap, St. John's Wort, or Valerian within 14 days prior to surgery
Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
Has known hypersensitivity to opioids, acetaminophen, or the inactive ingredients (excipients) of the Study Medication
Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years
Has impaired liver function, e.g., aspartate aminotransferase (AST)/Alanine transaminase (ALT)/bilirubin greater than or equal to 3.0 times the upper limit of normal, active hepatic disease, evidence of clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with Study Medication exposure

Show all 17Show fewer

Has been treated with monoamine oxidase inhibitors (MAOIs) within 7 days prior to surgery
Has participated in another clinical Study (investigational or marketed product) within 30 days of surgery
Post Operative Exclusion Criteria
The Subject must not meet any of the following criteria prior to randomization to Study Medication:
Had any other surgery than the planned laparoscopic surgery or had intra operative or post operative complications which in the view of the Investigator would make Study participation inadvisable
Has taken non steroidal anti-inflammatory drugs (NSAIDs), steroids or MAOIs during the day after surgery. Exceptions: The use of low-dose aspirin, e.g, 81 mg/day, for cardioprophylaxis, and limited use of topical or inhaled steroids are acceptable.
Had any neuraxial (spinal or epidural) opioid injected perioperatively
Had a local anesthetic injection (including into surgical wound at closure) or continuous infusion by any route
Had an epidural, regional, or percutaneous (intrawound) catheter with continuous local anesthetic infusion used for postoperative analgesic management
Had a fever (greater than 38.6 ºC or 101.5 ºF) requiring treatment
Post Operative Day 1 Randomization Criterion On the morning of the first post operative day (POD1), the Subject must have a categorical pain intensity score at rest of moderate or severe and a score ≥ 40 mm and ≤ 70 mm at rest on a 100 mm Visual Analogue Scale (VAS)

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Methodist Hospital
Arcadia, California, 91007
Visions Clinical Research
Boynton Beach, Florida, 33414
Cooper University Hospital
Camden, New Jersey, 08103
Nature Coast Clinical Research
Crystal River, Florida, 34429
G and G Research, Inc.
Ft. Pierce, Florida, 34950
Glendale Adventist Medical Center
Glendale, California, 91206
Memorial Herman/Memorial City Hospital
Houston, Texas, 77024
Texas Woman's Hospital
Houston, Texas, 77024
Physicians Clinical Research Corporation
Laguna Hills, California, 92653
Advanced Surgery Associates at Mercy Hospital
Miami, Florida, 33133
University of Miami School of Medicine
Miami, Florida, 33136
Huntington Memorial Hospital
Pasadena, California, 91105
Precision Trials
Phoenix, Arizona, 85032
William Beaumont Hospital (Royal Oak)
Royal Oak, Michigan, 48073
William Beaumont Hospital (Troy)
Royal Oak, Michigan, 48073
Helen Keller Hospital
Sheffield, Alabama, 35660
Staten Island University Hospital
Staten Island, New York, 10305

Other trials in United States

About this study

Official title: Phase 3 Randomized, Double-Blind Placebo-Controlled, Multicenter, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of IV Acetaminophen Versus Placebo for the Treatment of Postop Pain

Read the detailed description

To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.

Conditions: Pain
Being tested: IV Placebo, IV Acetaminophen
Keywords: Abdominal Laparoscopic Surgery
Medical subject headings: Pain

What participants receive

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

IV PlaceboDrug
Also called placebo
IV, every 6 hours for 24 hours (4 doses total)
IV PlaceboDrug
Also called placebo
IV, every 4 hours for 24 hours (6 doses total)
IV AcetaminophenDrug
Also called APAP, IV APAP
IV, every 6 hours for 24 hours (4 doses total)
IV AcetaminophenDrug
Also called APAP, IV APAP
IV, every 4 hours for 24 hours (6 doses total)

Study groups in NCT00564486
Study group	Role	What they receive
IV Placebo 100 ml	Placebo comparator	IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total). Receives: Drug: IV Placebo
IV Placebo 65 ml	Placebo comparator	IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total). Receives: Drug: IV Placebo
IV Acetaminophen 1 gm	Experimental	IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total). Receives: Drug: IV Acetaminophen
IV Acetaminophen 650 mg	Experimental	IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total). Receives: Drug: IV Acetaminophen

What is being measured

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

Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with "100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period.
Measured: Baseline to 24 hrs

Secondary outcomes (3)

Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with "0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period.
Measured: Baseline to 24 hrs
The Number of Subjects Reporting a Treatment Emergent Adverse Event
Number of subjects who experienced at least one treatment emergent adverse event (TEAE).
A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).
Measured: First dose through 7 day follow up
The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event
The number of subjects who reported at least one treatment emergent SAE during the study.
A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded study medication that:
- results in death
- is life-threatening
- requires inpatient hospitalization or causes prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- is a congenital anomaly/birth defect
- is an important medical event
Measured: First dose to 30 days after last dose of study medication.

Timeline

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

Nov 2007Sep 2008

First posted28 Nov 2007 (estimated)
Study startNov 2007
Primary completionSep 2008
Study completionSep 2008

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00564486
Sponsor's protocol ID: CPI-APA-304
Status last verified: Sep 2016
First submitted: 26 Nov 2007
Last updated: 21 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.
PubMed 21353105

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?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Randomized, Double-Blind Placebo-Controlled, Multicenter, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of IV Acetaminophen Versus Placebo for the Treatment of Postop Pain
ClinicalTrials.gov ID: NCT00564486
Acronym / sponsor ID: CPI-APA-304
Conditions: Pain
Keywords: Abdominal Laparoscopic Surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 28 Nov 2007 (estimated)
Results: Posted 30 Nov 2010

Clinical summary

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

Detailed description

To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
IV Placebo 100 ml	Placebo comparator	Drug: IV PlaceboIV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
IV Placebo 65 ml	Placebo comparator	Drug: IV PlaceboIV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
IV Acetaminophen 1 gm	Experimental	Drug: IV AcetaminophenIV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
IV Acetaminophen 650 mg	Experimental	Drug: IV AcetaminophenIV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Provide written Informed Consent prior to participation in the Study
Is scheduled to undergo abdominal laparoscopic surgery under general anesthesia (laparoscopic bariatric procedures, including gastric bypass or gastric banding, laparoscopic exploratory procedures in which no visceral dissection is performed, and laparoscopic procedures with minimal visceral dissection, such as laparoscopic sterilization,are excluded)
If Subject is a female of childbearing potential, have a negative pregnancy test within 21 days of surgery
Be at least 18, but not more than 80 years of age
Have a Body Mass Index (BMI) ≥ 19 and ≤ 40 lb/in2

Key exclusion criteria (17 listed)

Used opioids or tramadol daily for greater than 7 days prior to Study Medication administration (Subjects who, in the Investigator's opinion have or are developing opioid tolerance are to be excluded)
Has been treated with Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal, Skullcap, St. John's Wort, or Valerian within 14 days prior to surgery
Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
Has known hypersensitivity to opioids, acetaminophen, or the inactive ingredients (excipients) of the Study Medication
Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years

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
IV PlaceboAlso: placeboIV, every 6 hours for 24 hours (4 doses total)	Drug	IV Placebo 100 ml
IV PlaceboAlso: placeboIV, every 4 hours for 24 hours (6 doses total)	Drug	IV Placebo 65 ml
IV AcetaminophenAlso: APAP, IV APAPIV, every 6 hours for 24 hours (4 doses total)	Drug	IV Acetaminophen 1 gm
IV AcetaminophenAlso: APAP, IV APAPIV, every 4 hours for 24 hours (6 doses total)	Drug	IV Acetaminophen 650 mg

Primary outcome

Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
Time frame: Baseline to 24 hrs
Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with "100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period.

3 secondary outcomes

Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
Time frame: Baseline to 24 hrs
The Number of Subjects Reporting a Treatment Emergent Adverse Event
Time frame: First dose through 7 day follow up
The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event
Time frame: First dose to 30 days after last dose of study medication.

Results and safety

Results posted to the registry on 30 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous (IV) Placebo (100 ml)	43	36
IV Acetaminophen 1 gm	92	91
IV Acetaminophen 650 mg	42	39
IV Placebo (65 ml)	67	60

Primary outcome: Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)

Time frame: Baseline to 24 hrs. Mean (Standard Deviation). Unit: Units on a scale

Measure	IV Placebo n = 108	IV Acetaminophen 1 gm n = 92
Value	-45.2 (513.25)	-194.1 (593.62)

Population analysed: All efficacy analyses were conducted using the modified intent-to-treat (mITT) population, defined as those subjects who received at least one complete infusion of study medication prior to requesting rescue medication.Worst Observation Carried Forward (WOCF) imputation was applied after first rescue medication.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from T0 (on or after start of study drug) to Day 7 after surgery. Serious Adverse Events were collected from T0 to 30 days after the last dose of study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravenous (IV) Placebo (100 ml)	0 of 43 (0%)	12 of 43 (27.9%)	Not reported
IV Acetaminophen 1 gm	1 of 91 (1.1%)	42 of 91 (46.2%)	Not reported
IV Acetaminophen 650 mg	3 of 43 (7%)	16 of 43 (37.2%)	Not reported
IV Placebo (65 ml)	2 of 67 (3%)	27 of 67 (40.3%)	Not reported

Limitations and caveats (from the sponsor): One subject was randomized to receive IV APAP 1 g, but was administered IV APAP 650 mg. The subject was included in 1g IV APAP group for efficacy purposes and included in IV APAP 650 mg safety group for AE purposes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21353105Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IV Acetaminophen in people with Pain, run by Mallinckrodt at 17 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 8 inclusion and 17 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Nov 2010). 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 Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.) (time frame: Baseline to 24 hrs). 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 NCT00564486, which also lists 1 linked publication.

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 21 Oct 2016.