A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001 - Full Text View

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00382408

Purpose

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.

Condition	Intervention	Phase
Respiratory Tract Diseases	Biological: DR-5001 Other: Placebo	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Rate of febrile acute respiratory disease caused by wild type-4 adenovirus [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Seroconversion rates for wild type-7 adenovirus antibodies [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Seroconversion rates for wild type-4 adenovirus antibodies [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Rate of acute respiratory disease caused by wild type-4 adenovirus [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Rate of acute respiratory disease caused by wild type-7 adenovirus [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Adverse events and use of concomitant medications [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4000
Study Start Date:	September 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: DR-5001 1 tablet x 1
2: Placebo Comparator	Other: Placebo 1 tablet x 1

Detailed Description:

The study will be conducted at two sites and will include a minimum of 4 visits. The overall study duration for participants will be approximately 8 weeks. Study participants will undergo acute respiratory disease evaluation that will include a throat swab and a blood draw. Each participant will also be contacted in six months for follow-up information.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Military recruit in training
Male or female; if female, must be of non-childbearing potential or with a documented negative pregnancy test </= 72 hours prior to study medication administration and agree not to become pregnant

Exclusion Criteria:

Female nursing an infant or planning on nursing during the study
Immunosuppressed for any reason, including past (within last 6 months) or current treatment with immunosuppressive therapy
Known allergy to any component of the vaccines and/or placebo tablets
Immunocompromised sexual partner or immunocompromised individuals in home

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382408

Locations

United States, Illinois
Duramed Investigational Site
Great Lakes, Illinois, United States, 60088
United States, South Carolina
Duramed Investigational Site
Fort Jackson, South Carolina, United States, 29207

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

More Information

No publications provided

Responsible Party:	Duramed Research, Inc. ( Duramed Protocol Chair )
Study ID Numbers:	DR-ADV-301
Study First Received:	September 27, 2006
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00382408 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

Acute respiratory disease prevention
Adenovirus

Study placed in the following topic categories:

Respiratory Tract Diseases
Adenoviridae Infections
Respiration Disorders

Additional relevant MeSH terms:

Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 07, 2009