MULTICENTRIC PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ECOPIPAM IN THE MANAGEMENT OF OBESITY

Not Applicable

• Conditions: -E66 Obesity; Obesity; E66

• Registration Number: PER-012-00
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-02-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The subjects must be 18 years of age or older, of any gender and of any race.
• The subjects must have a BMl between 30 and 45, inclusive, measured at Scrutiny (Week -4).
• Subjects must be able to understand and be willing to give their informed consent and be able to adhere to the requirements of the study.
• Women should not be lactating and should not be able to get pregnant (ie, sterilized via hysterectomy or because they have tied their tubes or at least be menopausal since a year before) or if they are of childbearing age, agree to practice a barrier method of contraception effective, use an intrauterine abutment (lUD) or use contraceptive pills or an equivalent injectable contraceptive.

Exclusion Criteria

• Subjects who have participated in a clinical study and who have received a research drug in the 30 days prior to the Scrutiny.
• Subjects with a severe or unstable medical condition (e.g., recent surgery, stroke, myocardial infarction or neoplasia). Subjects with Parkinson´s disease, epilepsy, known EEG abnormalities, renal disease, neutropenia (neutrophils less than 1500 mm) and hepatic disease (e.g., viral or alcohol-induced hepatitis) will be excluded.
• Subjects with a severe or unstable psychiatric condition (e.g., schizophrenia, dementia or bipolar disorder) will be excluded.
• Subjects with diabetes or hypertension that require drug therapy.
• Subjects whose obesity is due to an identifiable metabolic or endocrinological syndrome such as the Cushing, Prader-Willi or Laurence-Moon-Bieldl syndromes.
• Clinical laboratory tests (e.g., blood chemistry, general urine) that are outside of normal limits that are clinically unacceptable to the Investigator or the Sponsor.
• Women who are pregnant or nursing.
• Subjects who have known hypersensitivity to ecopipam or any of its excipients.
• Subjects who have taken prohibited medications during the 60 days prior to the scrutiny
• Subjects with a known history of dependence on drugs or alcohol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified