Trial · NCT00564629
Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males
NCT00564629, Phase 3, Completed, Mallinckrodt; results first posted 2010-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males. Trials, record NCT00564629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00564629
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males
- NCT number
- NCT00564629
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 105 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Fever
- Interventions
- Intravenous acetaminophen plus oral placebo, Oral acetaminophen plus IV placebo, Reference standard endotoxin (RSE)
- First posted
- 2007-11-28
- Last updated
- 2016-10-19
- Results first posted
- 2010-09-21
- Limitations and caveats
- Protocol and statistical analysis plan were amended to clarify endpoints prior to database lock and analysis.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2) | 0-2 hours | This outcome measures when the antipyretic effect begins by statistical analysis of WSTD2, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 2 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. |
| Secondary | Time to a Reduction in Temperature From T0 to T360 Minutes. | 6 hours | This outcome measures how much time it took to observe a decrease in subjects' core body temperature by 0.8 ºC, 1.0 ºC, and 1.5 ºC from the temperature at T0 and from the temperature at the peak after T0 through T360 (6 hours). The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. |
| Secondary | Maximum Temperature Reduction Observed From T0 to T360 Minutes | T0-T360 minutes | This outcome measures the maximum core temperature reduction observed from T0 to T360 minutes. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. |
| Secondary | Subject's Global Evaluation of Study Medication at T360 Minutes | T360 minutes | This outcome measures how satisfied the subject was with the study treatment. The subject was asked to answer "Overall, how would you rate study treatments?" at T360 minutes using a 4-point categorical scale (0=poor, 1=fair, 2=good, 3=excellent). |
| Secondary | The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes | T0 to T360 minutes | This outcome measures what percentage of total subjects had a temperature \< 38 ºC and \< 38.5 ºC at any timepoint during the time from T0 to T360 minutes. |
| Secondary | WSTD3 | 0-3 hours | This outcome measure is a statistical analysis of WSTD3, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 3 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. |
| Secondary | WSTD4 | 0-4 hours | This outcome measure is a statistical analysis of WSTD4, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 4 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. |
| Secondary | WSTD5 | 0-5 hours | This outcome measure is a statistical analysis of WSTD5, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 5 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. |
| Secondary | WSTD6 | 0-6 hours | This outcome measure is a statistical analysis of WSTD6, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 6 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2) | 0-2 hours | mITT population defined as all randomized subjects who received at least 1 full dose of oral study medication (subject not vomiting within 2 hours after oral study drug) or 1 full dose of IV study medication(subject having received all 100 mls solution). This analysis was performed with imputation for non-physiological temperature swing zone effect | Degrees Celsius | MEAN |
| SECONDARY | Time to a Reduction in Temperature From T0 to T360 Minutes. | 6 hours | Analysis was performed on the mITT population. | Hours | MEAN |
| SECONDARY | Maximum Temperature Reduction Observed From T0 to T360 Minutes | T0-T360 minutes | Analysis performed on the mITT population. | Degrees Celsius | MEAN |
| SECONDARY | Subject's Global Evaluation of Study Medication at T360 Minutes | T360 minutes | Analysis performed on the mITT population. | participants | NUMBER |
| SECONDARY | The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes | T0 to T360 minutes | Analysis performed on mITT population. | percentage of participants | NUMBER |
| SECONDARY | WSTD3 | 0-3 hours | degrees Celsius | MEAN | |
| SECONDARY | WSTD4 | 0-4 hours | degrees Celsius | MEAN | |
| SECONDARY | WSTD5 | 0-5 hours | degrees Celsius | MEAN | |
| SECONDARY | WSTD6 | 0-6 hours | degrees Celsius | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2) | IV APAP 1 g / 100 ml Solution | 0.3 | Standard Deviation 0.41 | Degrees Celsius | |
| The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2) | PO APAP 1 g | 0.6 | Standard Deviation 0.55 | Degrees Celsius | |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | IV APAP 1 g / 100 ml Solution | reduction in temperature of 0.8 ºC from T0 temp | 4.8 | Standard Deviation 0.96 | Hours |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | PO APAP 1 g | reduction in temperature of 0.8 ºC from T0 temp | 4.7 | Standard Deviation 1.41 | Hours |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | IV APAP 1 g / 100 ml Solution | reduction in temp of 0.8 ºC from the peak T0-T360 | 3.5 | Standard Deviation 1.23 | Hours |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | PO APAP 1 g | reduction in temp of 0.8 ºC from the peak T0-T360 | 2.4 | Standard Deviation 1.16 | Hours |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | IV APAP 1 g / 100 ml Solution | reduction in temperature of 1.0 ºC from T0 temp | 5.1 | Standard Deviation 0.85 | Hours |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | PO APAP 1 g | reduction in temperature of 1.0 ºC from T0 temp | 5.0 | Standard Deviation 1.24 | Hours |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | IV APAP 1 g / 100 ml Solution | reduction in temp of 1.0 ºC from the peak T0-T360 | 3.8 | Standard Deviation 0.87 | Hours |
| Time to a Reduction in Temperature From T0 to T360 Minutes. | PO APAP 1 g | reduction in temp of 1.0 ºC from the peak T0-T360 | 2.9 | Standard Deviation 1.16 | Hours |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Acetaminophen (PO APAP) 1 g | 51 | |
| Overall Study | STARTED | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 54 | |
| Overall Study | COMPLETED | Oral Acetaminophen (PO APAP) 1 g | 36 | |
| Overall Study | COMPLETED | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 45 | |
| Overall Study | NOT COMPLETED | Oral Acetaminophen (PO APAP) 1 g | 15 | |
| Overall Study | NOT COMPLETED | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 9 |
Source ClinicalTrials.gov
Adverse events6
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 | Diarrhoea | Gastrointestinal disorders | Oral Acetaminophen (PO APAP) 1 g | 5 | 51 | |
| other | Diarrhoea | Gastrointestinal disorders | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 4 | 54 | |
| other | Vomiting | Gastrointestinal disorders | Oral Acetaminophen (PO APAP) 1 g | 13 | 51 | |
| other | Vomiting | Gastrointestinal disorders | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 6 | 54 | |
| other | Headache | Nervous system disorders | Oral Acetaminophen (PO APAP) 1 g | 4 | 51 | |
| other | Headache | Nervous system disorders | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 5 | 54 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Acetaminophen (PO APAP) 1 g | ||
| Total, all-cause mortality | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | ||
| Total, other adverse events | Oral Acetaminophen (PO APAP) 1 g | 17 | 51 |
| Total, other adverse events | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 13 | 54 |
| Total, serious adverse events | Oral Acetaminophen (PO APAP) 1 g | 0 | 51 |
| Total, serious adverse events | Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution | 0 | 54 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Oral Acetaminophen (PO APAP) 1 g vs Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution: serious adverse events |
Source Trial comparisons
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/NCT00564629
GET https://conductscience.org/api/trials/v1/NCT00564629/results?page=2