Phase 2
N=14
Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
Sensitivity in Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT01019928 ↗Enrolled (actual)
14
Serious AEs
3.7%
Results posted
Nov 2012
Primary outcome: Primary: Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose. — 84.0; 86.9 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD1386 (Drug); Placebo to AZD1386 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose. |
84.0; 86.9 | — |
| SECONDARY Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose |
86.0; 87.8 | — |
| SECONDARY Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose |
85.5; 77.0 | — |
| SECONDARY Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose |
16.2; 15.1 | — |
| SECONDARY Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose |
15.0; 16.7 | — |
| SECONDARY Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose. |
15.4; 15.2 | — |
| SECONDARY Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose |
16.7; 16.7 | — |
| SECONDARY Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose |
16.7; 15.8 | — |
| SECONDARY Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose |
16.2; 14.8 | — |
| SECONDARY AUCt |
5899 | — |
| SECONDARY Cmax |
2361 | — |
| SECONDARY Tmax |
1.0 | — |
| SECONDARY SBP |
145.8; 139.7 | — |
| SECONDARY DBP |
81.4; 80.0 | — |
| SECONDARY Pulse |
67.8; 62.2 | — |
| SECONDARY QTcF |
409.6; 414.3 | — |
| SECONDARY Body Temperature |
37.2; 36.8 | — |
| SECONDARY Clinically Relevant Change of Laboratory Variables |
0; 0 | — |
Summary
The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent form
- BMI 18.5-35.0, inclusive
- Continuous PPI treatment for GERD during the last 4 weeks
Exclusion Criteria
- Patients that have not experienced any GERD symptoms improvement at all after PPI treatment
- Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD
- Prior surgery of the upper GI tract
Data sourced from ClinicalTrials.gov (NCT01019928). 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.