None listed
Conditions
Interventions
Ecopipam 50 mg Type of group
Ecopipam 50 mg QD HS will be given for 52 weeks.
Group name:Open Treatment Period Type of group
All ecopipam 100 mg QD HS patients will be administered for an additional 52 weeks. The dose can be reduced to 50 mg in case of intolerance.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The final point of variable primary efficacy will be distribution of the percentage of body weight loss at the end of the double-blind treatment phase of one year (the proportion of subjects with body weight loss of 5% and 10% from the random distribution will be focused). Measure:Efficacy Timepoints:4 weeks after completing the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The Common Toxicity Criteria (CTC) graduation system will be used to assess the severity of adverse events. For adveros events that are not mentioned in the CTC system, the following will be used definitions: Mild: you are aware of the sign, symptom or event, but they are easily tolerated. Moderate: enough annoyance to cause interference with your usual activity and may require Intervention. Severe: disabling, Prevents the activities usual or considerably affects the clinical state, and requires intervention. They endanger life: immediate risk of death. Measure:Safety Timepoints:During the administration of treatment | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed