Phase 2
Completed N=27
TLESR-impedance Study in Patients
Reflux Episodes
Source: ClinicalTrials.gov NCT00743444 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose — 11.6; 15.5 Relaxations
Summary
The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose |
11.6; 15.5 | — |
| SECONDARY Total Number Reflux Episodes 0-24 Hours Post First Dose |
30.6; 50.5 | — |
| SECONDARY Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method. |
7.16 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of written consent
- GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
- 6 months history of GERD and incomplete response to PPI treatment
Exclusion Criteria
- Insufficient symptom burden of the reflux disease evaluated by questionnaires
- S-creatinine >1.2 times upper limit of normal
- History of heart disease
- Prior surgery of the upper GI tract
Data sourced from ClinicalTrials.gov (NCT00743444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.