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NCT02689999
The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity
Phase 4 trial testing Dexrabeprazole 10 mg Enteric-Coated Tablets in Gastroesophageal Reflux Disease (GERD) in 12 participants. Completed in 1 August 2017.
1 May 2017
Quick facts
| Lead sponsor | Neutec Ar-Ge San ve Tic A.Ş |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 February 2016 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 August 2017 |
| Sites | 3 locations across Turkey (Türkiye) |
Drugs / interventions tested
- Dexrabeprazole 10 mg Enteric-Coated Tablets — full drug profile →
Conditions studied
- Gastroesophageal Reflux Disease (GERD) — all drugs for Gastroesophageal Reflux Disease (GERD) →
Sponsor
Neutec Ar-Ge San ve Tic A.Ş — full company profile →
Who can join
Adults 18 to 70, any sex, with Gastroesophageal Reflux Disease (GERD). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
- The percent of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Time frame: One week
Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia. -
- The area under curve (AUC) of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.
Time frame: One week
Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia.
Sponsor's own description
It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and impedance kinetics.
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 NCT02689999
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastroesophageal Reflux Disease (GERD)
Currently open trials in the same condition.
- NCT02616302 — A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux · Phase 2 · recruiting
- NCT07174882 — Evaluation of the Clinical Course of NERD and Assessment of the Esophageal Mucosa Resistance · active not recruiting
- NCT05870163 — Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment · recruiting
- NCT06862037 — Development of Machine Learning Models to Predict Postoperative GERD Symptom Resolution After Laparoscopic Nissen Fundop · active not recruiting
Other Neutec Ar-Ge San ve Tic A.Ş trials
Trials by the same sponsor.
- NCT05890638 — Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combinati · Phase 3 · unknown
- NCT03177746 — The Safety of Dapoxetine/Tadalafil Combination Therapy · Phase 4 · unknown
- NCT04457323 — S-Metoprolol XR 25-50 mg Tablets vs Metoprolol Zok 50-100 mg Tablets in Hypertension Patients. · Phase 4 · unknown
- NCT04446637 — Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhale · Phase 3 · withdrawn
- NCT03954613 — Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease · Phase 4 · unknown
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 NCT02689999 (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 Neutec Ar-Ge San ve Tic A.Ş
- Last refreshed: 23 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02689999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing