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A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain

This study has been completed.

Sponsors and Collaborators: Corcept Therapeutics
Eli Lilly and Company
Information provided by: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00455442
  Purpose

This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.


Condition Intervention Phase
Weight-Gain Prevention
Drug: Mifepristone
Phase II

Drug Information available for:   Olanzapine    Mifepristone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.

Secondary Outcome Measures:
  • To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.

Enrollment:   57
Study Start Date:   March 2007
Study Completion Date:   July 2007

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Healthy male volunteers between 18 and 40 years of age
  • BMI between ≥ 18 and ≤ 25
  • Able to provide written informed consent
  • Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits

Exclusion Criteria:

  • History of Cushing's syndrome or Addison's disease
  • Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
  • Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
  • Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
  • Have a history of an allergic reaction to either mifepristone or olanzapine
  • Any clinically significant abnormality on screening laboratory tests
  • QTc Bazzett's ≥ 450 msec
  • Any major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
  • Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
  • History of recent (within 6 months of screening) significant weight fluctuation
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455442

Locations
India
St. John's Medical College    
      Bangalore, India

Sponsors and Collaborators
Corcept Therapeutics
Eli Lilly and Company

Investigators
Study Director:     Thad Block, MD     Corcept Therapeutics    
  More Information


Corcept Therapeutics official website  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   C-1073-200
First Received:   March 30, 2007
Last Updated:   September 18, 2008
ClinicalTrials.gov Identifier:   NCT00455442
Health Authority:   United States: Food and Drug Administration;   India: Institutional Review Board

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Olanzapine
Body Weight Changes
Mifepristone
Healthy
Weight Gain

Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on October 22, 2008




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