Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses

This study has been completed.

Sponsor:

Collaborators:

Hill Top Research

TKL Research, Inc.

Information provided by (Responsible Party):

The Dial Corporation

ClinicalTrials.gov Identifier:

NCT00762476

First received: September 26, 2008

Last updated: March 21, 2012

Last verified: March 2012

History of Changes

Results First Received: February 8, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Common Cold
Interventions:	Drug: 3804-250A Drug: 3804-291

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Modified AV Lotion without active ingredients.
3804-250A	Experimental AV Lotion

Participant Flow: Overall Study

	Placebo	3804-250A
STARTED	206	205
COMPLETED	183	169
NOT COMPLETED	23	36
Adverse Event	7	1
Lost to Follow-up	2	0
Protocol Violation	5	6
Physician Decision	2	14
Withdrawal by Subject	6	12
antibiotic use	0	1
non-compliance with study visits	0	2
Seasonal allergies	1	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Modified AV Lotion without active ingredients.
3804-250A	Experimental AV Lotion
Total	Total of all reporting groups

Baseline Measures

	Placebo	3804-250A	Total
Number of Participants [units: participants]	206	205	411
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	203	200	403
>=65 years	3	5	8
Age [units: years] Mean ± Standard Deviation	37.3 ± 14.56	36.2 ± 14.23	36.7 ± 14.39
Gender [units: participants]
Female	150	155	305
Male	56	50	106
Region of Enrollment [units: participants]
United States	206	205	411

Outcome Measures

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1. Primary:

The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. [ Time Frame: 10 weeks ]

Measure Type	Primary
Measure Title	The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.
Measure Description	Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group
Time Frame	10 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.

Reporting Groups

	Description
Placebo	Modified AV Lotion without active ingredients
3804-250A	Experimental AV Lotion

Measured Values

	Placebo	3804-250A
Number of Participants Analyzed [units: participants]	206	205
The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. [units: cold illnesses per 100 subjects]	47.1	43.9

Statistical Analysis 1 for The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.

Groups ^[1]	All groups
Method ^[2]	Poisson regression
P Value ^[3]	>0.5000

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2. Secondary:

Rhinovirus Infections. [ Time Frame: 10 weeks ]

Measure Type	Secondary
Measure Title	Rhinovirus Infections.
Measure Description	The incidence of rhinovirus infections
Time Frame	10 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.

Reporting Groups

	Description
Placebo	Modified AV Lotion without active ingredients.
3804-250A	Experimental AV Lotion

Measured Values

	Placebo	3804-250A
Number of Participants Analyzed [units: participants]	206	205
Rhinovirus Infections. [units: rhinovirus infections per 100 subjects]	58.7	59.0

Statistical Analysis 1 for Rhinovirus Infections.

Groups ^[1]	All groups
Method ^[2]	Poisson regression
P Value ^[3]	>0.5000

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Secondary:

Rhinovirus-associated Colds [ Time Frame: 10 weeks ]

Measure Type	Secondary
Measure Title	Rhinovirus-associated Colds
Measure Description	The incidence of rhinovirus-associated cold illnesses.
Time Frame	10 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.

Reporting Groups

	Description
Placebo	Modified AV Lotion without active ingredients.
3804-250A	Experimental AV Lotion

Measured Values

	Placebo	3804-250A
Number of Participants Analyzed [units: participants]	206	205
Rhinovirus-associated Colds [units: RV-associated cold illnesses per 100 sub]	24.3	20.0

Statistical Analysis 1 for Rhinovirus-associated Colds

Groups ^[1]	All groups
Method ^[2]	Poisson regression
P Value ^[3]	0.3451

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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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: The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period 1 year after study completion.

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
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Results Point of Contact:

Name/Title: Dr. Ronald Turner
Organization: University of Virginia
phone: (434) 243-9864
e-mail: RBT2N@hscmail.mcc.virginia.edu

No publications provided

Responsible Party:	The Dial Corporation
ClinicalTrials.gov Identifier:	NCT00762476 History of Changes
Other Study ID Numbers:	TM&R-0062-08-TXC, CS990108, 13805
Study First Received:	September 26, 2008
Results First Received:	February 8, 2012
Last Updated:	March 21, 2012
Health Authority:	United States: Food and Drug Administration

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