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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004811-21-BE

Enrollment

Registered

2011-10-10

Start date

2011-11-07

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

study is conducted on healthy volunteers, no medical condition is investigated

Interventions

Trade Name: Viagra Product Name: Viagra Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SILDENAFIL CAS Number: 139755-83-2 Current Sponsor code: sildenafil Other descriptive name: viagra

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 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: given the role of PDE enzymes in the process of gastric relaxation on the one hand and posibble relation between impaired gastric accommodation and satiation on the other hand, we aimed to investigate the effect of sildenafil on the relation between gastric motility, gastric emptying and food intake during nutrient infusion.;Secondary Objective: none;Primary end point(s): Intragastric pressure profiles, magnitude of initial pressure drop and slope of recovery of intragastric pressures during continued infusion of a nutrient drink will be compared. The experiment is finished at maximum satiation. For gastric emptying, gastric emptying parameters after ingestion of a standard meal will be compared.;Timepoint(s) of evaluation of this end point: after ending of all experiments	—

Measure

Time frame

Main Objective: given the role of PDE enzymes in the process of gastric relaxation on the one hand and posibble relation between impaired gastric accommodation and satiation on the other hand, we aimed to investigate the effect of sildenafil on the relation between gastric motility, gastric emptying and food intake during nutrient infusion.;Secondary Objective: none;Primary end point(s): Intragastric pressure profiles, magnitude of initial pressure drop and slope of recovery of intragastric pressures during continued infusion of a nutrient drink will be compared. The experiment is finished at maximum satiation. For gastric emptying, gastric emptying parameters after ingestion of a standard meal will be compared.;Timepoint(s) of evaluation of this end point: after ending of all experiments

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Belgium

Contacts

Public ContactSofie Verschueren

KULeuven

sofie.verschueren@med.kuleuven.be32 1633 08 24

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026