Methods Study to Characterize Early Indicators of Weight Loss in People

NCT00383253

Last updated date
Study Location
Pfizer Investigational Site
Adelaide, South Australia, 5000, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Females, those with illnesses expected to cause weight loss, those without stable body
weight within 3 months of screening.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Methods Study to Characterize Early Indicators of Weight Loss in People
Official Title  ICMJE A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects.
Brief Summary Methods study to characterize early indicators of weight loss in people.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: caloric restriction - 10%
    Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
  • Behavioral: caloric restriction - 25%
    Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
  • Behavioral: caloric restriction - 50%
    Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
  • Behavioral: caloric restriction - Control
    Subjects maintained on their baseline caloric intake (caloric restriction = none)
Study Arms  ICMJE
  • Experimental: 10%
    Intervention: Behavioral: caloric restriction - 10%
  • Experimental: 25%
    Intervention: Behavioral: caloric restriction - 25%
  • Experimental: 50%
    Intervention: Behavioral: caloric restriction - 50%
  • Placebo Comparator: Control
    Intervention: Behavioral: caloric restriction - Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2009)
57
Original Enrollment  ICMJE
 (submitted: October 2, 2006)
48
Actual Study Completion Date  ICMJE March 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2

Exclusion Criteria:

  • Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00383253
Other Study ID Numbers  ICMJE A9001342
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • University of Adelaide
  • Royal Adelaide Hospital
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP