Trial · NCT00598559
Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
NCT00598559, Phase 3, Completed, Mallinckrodt; results first posted 2010-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients. Trials, record NCT00598559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00598559
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
- NCT number
- NCT00598559
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 213 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Acute Pain, Fever
- Interventions
- IV Acetaminophen
- First posted
- 2008-01-22
- Last updated
- 2016-10-21
- Results first posted
- 2010-12-10
- Limitations and caveats
No separate efficacy analyses were performed for the fever because only 1 subject in each active group had fever as an indication, and no subject had both pain and fever as indications for treatment with IV acetaminophen.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). | T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up | 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). |
| Primary | Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE) | First dose (T0) to within 30 days of the last dose of study medication. | Serious TEAE is any untoward medical occurrences at any dose of 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 |
| Secondary | Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments | End of Day 5 (prior to discharge) | Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge) |
| Secondary | Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period. | Study period lookback at Day 7 | Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments | End of Day 5 (prior to discharge) | Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group. | Units on a scale | MEAN |
| PRIMARY | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). | T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up | Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group. | Participants | NUMBER |
| PRIMARY | Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE) | First dose (T0) to within 30 days of the last dose of study medication. | Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group. | Participants | NUMBER |
| SECONDARY | Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period. | Study period lookback at Day 7 | Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments | IV Acetaminophen 1 g q6h | 2.5 | Standard Deviation 0.78 | Units on a scale | |
| Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments | IV Acetaminophen 650 mg q4h | 2.5 | Standard Deviation 0.67 | Units on a scale | |
| Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments | Standard of Care (SOC) | 2.0 | Standard Deviation 0.85 | Units on a scale | |
| Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). | IV Acetaminophen 1 g q6h | 77 | Participants | ||
| Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). | IV Acetaminophen 650 mg q4h | 86 | Participants | ||
| Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE). | Standard of Care (SOC) | 26 | Participants | ||
| Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE) | IV Acetaminophen 1 g q6h | 14 | Participants | ||
| Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE) | IV Acetaminophen 650 mg q4h | 11 | Participants | ||
| Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE) | Standard of Care (SOC) | 3 | Participants | ||
| Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period. | IV Acetaminophen 1 g q6h | 2.4 | Standard Deviation 0.75 | Units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV Acetaminophen 1 Gram Every 6 Hours | 92 | |
| Overall Study | STARTED | IV Acetaminophen 650 Milligram Every 4 Hours | 91 | |
| Overall Study | STARTED | Standard of Care (SOC) | 30 | |
| Overall Study | COMPLETED | IV Acetaminophen 1 Gram Every 6 Hours | 65 | |
| Overall Study | COMPLETED | IV Acetaminophen 650 Milligram Every 4 Hours | 63 | |
| Overall Study | COMPLETED | Standard of Care (SOC) | 27 | |
| Overall Study | NOT COMPLETED | IV Acetaminophen 1 Gram Every 6 Hours | 27 | |
| Overall Study | NOT COMPLETED | IV Acetaminophen 650 Milligram Every 4 Hours | 28 | |
| Overall Study | NOT COMPLETED | Standard of Care (SOC) | 3 |
Source ClinicalTrials.gov
Adverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | IV Acetaminophen 1 Gram Every 6 Hours | 11 | 92 | |
| other | Anaemia | Blood and lymphatic system disorders | IV Acetaminophen 650 Milligram Every 4 Hours | 10 | 91 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) | 6 | 30 | |
| other | Breath sounds abnormal | Investigations | IV Acetaminophen 1 Gram Every 6 Hours | 7 | 92 | |
| other | Breath sounds abnormal | Investigations | IV Acetaminophen 650 Milligram Every 4 Hours | 6 | 91 | |
| other | Breath sounds abnormal | Investigations | Standard of Care (SOC) | 1 | 30 | |
| other | Constipation | Gastrointestinal disorders | IV Acetaminophen 1 Gram Every 6 Hours | 18 | 92 | |
| other | Constipation | Gastrointestinal disorders | IV Acetaminophen 650 Milligram Every 4 Hours | 21 | 91 | |
| other | Constipation | Gastrointestinal disorders | Standard of Care (SOC) | 5 | 30 | |
| other | Headache | Nervous system disorders | IV Acetaminophen 1 Gram Every 6 Hours | 7 | 92 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Acetaminophen 1 Gram Every 6 Hours | ||
| Total, all-cause mortality | IV Acetaminophen 650 Milligram Every 4 Hours | ||
| Total, all-cause mortality | Standard of Care (SOC) | ||
| Total, other adverse events | IV Acetaminophen 1 Gram Every 6 Hours | 60 | 92 |
| Total, other adverse events | IV Acetaminophen 650 Milligram Every 4 Hours | 68 | 91 |
| Total, other adverse events | Standard of Care (SOC) | 18 | 30 |
| Total, serious adverse events | IV Acetaminophen 1 Gram Every 6 Hours | 14 | 92 |
| Total, serious adverse events | IV Acetaminophen 650 Milligram Every 4 Hours | 11 | 91 |
| Total, serious adverse events | Standard of Care (SOC) | 3 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00598559
GET https://conductscience.org/api/trials/v1/NCT00598559/events?page=2