The effect of Sildenafil citrate (Viagra ®) on stomach motility, gastric emptying and food intake in healthy volunteers

Phase 1

• Conditions: study is conducted on healthy volunteers, no medical condition isinvestigated; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2011-004811-21-BE
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-10
• Study Completion: 2013-01-25
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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 20 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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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.
• There is a possibility of becoming pregnant during the study period.
• Body mass index > 25

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified