Trials / Unknown
UnknownNCT03676374
Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease
A Placebo-controlled Trial With Prucalopride for the Treatment of Typical Reflux Symptoms in Patients With Gastro-esophageal Reflux Disease With Incomplete Proton Pump Inhibitor Response
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Up to date there is no placebo-controlled trial to investigate the effect of prucalopride in patients with proven refractory GERD. Therefore, to evaluate the efficacy of prucalopride on the improvement in symptom severity and reflux parameters, we will conduct a randomized, parallel, placebo-controlled, single-blind study. 60 patients with refractory GERD symptoms will receive either placebo or prucalopride (Resolor®) 2 mg for a period of 4 weeks. Symptom severity will be assessed by a validated reflux questionnaire (ReQuest) and reflux parameters (acid exposure time and number of reflux episodes) will be assessed by means of a 24 hour impedance-pH monitoring.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Prucalopride | Prucalopride 2mg taken once a day as add-on to PPI (2x/d) |
| DRUG | Placebo Oral Tablet | Placebo tablet taken once a day as add-on to PPI (2x/d) |
Timeline
- Start date
- 2019-02-18
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2018-09-18
- Last updated
- 2019-12-05
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03676374. Inclusion in this directory is not an endorsement.