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NCT00951431
Gastric Functions & Proton Pump Inhibitor( PPI) Study
Phase 4 trial testing Esomeprazole in Functional Dyspepsia in 155 participants. Completed in 19 February 2016.
31 December 2015
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 155 |
| Start date | 3 December 2009 |
| Primary completion | 31 December 2015 |
| Estimated completion | 19 February 2016 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Esomeprazole (esomeprazole) — full drug profile →
- Placebo
Conditions studied
- Functional Dyspepsia — all drugs for Functional Dyspepsia →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 18 to 60, any sex, with Functional Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Functional dyspepsia is one of the most common digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the first line treatment for functional dyspepsia. However, the mechanism of symptom relief is unclear. Most of the previous studies were performed on healthy volunteers who received only a very short course of PPI. The correlation between symptom and gastric emptying is lacking in these studies. Demographic data and anthropometric measurements will be obtained for baseline assessment. Patients are required to complete FGI Screening Questionnaire, Functional dyspepsia symptom questionnaire, gastroesophageal reflux disease (GERD) symptom questionnaire and irritable bowel syndrome (IBS) symptom questionnaire to have a thorough assessment of their GI symptoms. (1) Satiety test and ghrelin profile, and (2)gastric emptying test will be arranged as two individual visits. After baseline investigations, patients will be randomly assigned to either Nexium 20 mg daily or identical looking placebo for 8 weeks. The patients will report their individual dyspeptic symptoms on weekly basis using a self-administered symptom questionnaire. Satiety test and ghrelin profile, gastric emptying study will be repeated at the end of 8-week treatment. Hypothesis: Long-term PPI relieves dyspeptic symptom through acceleration of gastric emptying rate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00951431
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00951431 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 1 February 2019
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