study is conducted on healthy volunteers, no medical condition is investigated
Conditions
Interventions
Trade Name: Acomplia
Product Name: Acomplia
Pharmaceutical Form: Tablet
INN or Proposed INN: RIMONABANT
CAS Number: 168273-06-1
Current Sponsor code: rimonabant
Other descriptive name: acomplia
Concen
Sponsors
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers will be recruited from an existing mailing list. The volunteers will have to agree to participate in both studies as described below. In total 10 healthy volunteers (18-45 years) will be recruited Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are excluded from participation if: • Their age is not between 18 and 45 years old. • They have relevant underlying disease (cardia, pulmonary, metabolic, kidney or liver disease, … ) • They have a history of esophageal or gastric surgery, or recurrent or intermittent upper gastrointestinal symptoms (upper abdominal pain, nausea, vomiting, bothersome fullness or early satiation, heartburn, regurgitation,…) • They have a history of allergy to several types of drugs or food. • They have ever been treated for depression or had episodes of depression (using validated tests) • They use cannabinoids. • There is a possibility of becoming pregnant during the study period. • Body mass index > 25
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Given the putative role of CB1 receptors in intestinal sensitivity on the one hand and possible relation between impaired GA and satiation on the other hand we set out to investigate the effect of rimonabant on: 1) Esophageal sensitivity to different stimuli. 2) The relation between GA and satiation during intragastric nutrient drink infusion ;Secondary Objective: none;Primary end point(s): Esophageal sensitivity for the different stimuli (chemical, heat, mechanical and electrical) will be compared between rimonabant and placebo conditions. Intragastric pressure profiles, magnitude of initial pressure drop and slope of recovery of intragastric pressures during continued infusion of different liquids and intragastric volumes will be compared ;Timepoint(s) of evaluation of this end point: when all experiments are finished | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
Belgium
Contacts
Public ContactPieter Janssen
KULeuven
Outcome results
None listed