Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

This study has been completed.

Study NCT00493311 Information provided by Cadence Pharmaceuticals

First Received on June 27, 2007. Last Updated on November 29, 2010 History of Changes

Results First Received: September 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Fever
Interventions:	Drug: IV Placebo Drug: IV Acetaminophen Biological: Reference Standard Endotoxin (RSE)

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at a single clinical research facility in the United States during July to September 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects received intravenous endotoxin to induce fever and were then randomized to receive either 1 g acetaminophen in 100 ml intravenous solution or 100 ml placebo solution.

Reporting Groups

	Description
Intravenous (IV) Placebo	After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
Intravenous (IV) Acetaminophen 1 g	After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution

Participant Flow: Overall Study

	Intravenous (IV) Placebo	Intravenous (IV) Acetaminophen 1 g
STARTED	29	31
COMPLETED	27	29
NOT COMPLETED	2	2
Need for rescue medication	2	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Intravenous (IV) Placebo	After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
Intravenous (IV) Acetaminophen 1 g	After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution

Baseline Measures

	Intravenous (IV) Placebo	Intravenous (IV) Acetaminophen 1 g	Total
Number of Participants [units: participants]	29	31	60
Age [units: participants]
<18 years	0	0	0
Between 18 and 65 years inclusive	29	31	60
>65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	30.0 ± 10.02	29.7 ± 7.35	29.9 ± 8.67
Gender ^[1] [units: participants]
Female	0	0	0
Male	29	31	60
Region of Enrollment [units: participants]
United States	29	31	60

[1]	Only male subjects were allowed to participate in the study.

Outcome Measures

Show All Outcome Measures

1. Primary:

Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever [ Time Frame: Baseline (T0) to 6 hours post study drug administration ]

Show Outcome Measure 1

2. Secondary:

Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever. [ Time Frame: Baseline (T0) to 3 hours ]

Show Outcome Measure 2

3. Secondary:

Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration) [ Time Frame: Baseline (T0) to 360 minutes (6 hours) post study drug administration ]

Show Outcome Measure 3

4. Secondary:

The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration) [ Time Frame: 360 minutes (6 hours after study drug administration) ]

Show Outcome Measure 4

5. Secondary:

Global Assessment of Treatment at T360 Minutes or Early Termination. [ Time Frame: Baseline (T0) to 6 hours ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigator may publish only after cooperative publication or 18 months after sponsor's final evaluation of study data, whichever occurs first. At least 60 days prior to submission for publication, investigator must submit manuscript to sponsor for review and comment. Sponsor has 60 day period thereafter to respond with comment. Investigator will remove confidential information at the request of sponsor.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Mike Royal, MD JD MBA, Clinical Development Analgesics
Organization: Cadence Pharmaceuticals
phone: 858-436-1400
e-mail: mroyal@cadencepharm.com

No publications provided

Responsible Party:	Mike Royal, MD, JD, MBA- Vice President Clinical Development-Analgesics, Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00493311 History of Changes
Other Study ID Numbers:	CPI-APF-302
Study First Received:	June 27, 2007
Results First Received:	September 25, 2009
Last Updated:	November 29, 2010
Health Authority:	United States: Food and Drug Administration