Clinical trial NCT01019928: Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
Official title: A Phase IIa, Double-blind, Randomized, 2-way Cross-over Study to Evaluate the Effect of a Single Dose of AZD1386 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity in GERD Patients With a Partial Response to PPI Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sensitivity in Esophagus
Keywords: GERD
patient
esophagus
pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
timeFrame: 1.5 hours post dose
Secondary outcomes:
measure: Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose
timeFrame: 0.5 hours post dose
measure: Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose
timeFrame: 2.5 hours post dose
measure: Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose
timeFrame: 0.5 hours post dose
measure: Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose
timeFrame: 1.5 hours post dose
measure: Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.
timeFrame: 2.5 hours post dose
measure: Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose
timeFrame: 0.5 hours post dose
measure: Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose
timeFrame: 1.5 hours post dose
measure: Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose
timeFrame: 2.5 hours post dose
measure: AUCt
timeFrame: 0 to 4 hours post dose
measure: Cmax
timeFrame: 0 to 4 hours post dose
measure: Tmax
timeFrame: 0 to 4 hours post dose
measure: SBP
timeFrame: 1.5 hours post dose
measure: DBP
timeFrame: 1.5 hours post dose
measure: Pulse
timeFrame: 1.5 hours post dose
measure: QTcF
timeFrame: 1.5 hours post dose
measure: Body Temperature
timeFrame: 1.5 hours post dose
measure: Clinically Relevant Change of Laboratory Variables
timeFrame: Pre-entry to follow-up
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
state: Vastra Gotaland
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Marie Sundin
role: STUDY_DIRECTOR
affiliation: Aarhus Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
name: Peter Funch-Jensen,, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krarup AL, Ny L, Gunnarsson J, Hvid-Jensen F, Zetterstrand S, Simren M, Funch-Jensen P, Hansen MB, Drewes AM. Randomized clinical trial: inhibition of the TRPV1 system in patients with nonerosive gastroesophageal reflux disease and a partial response to PPI treatment is not associated with analgesia to esophageal experimental pain. Scand J Gastroenterol. 2013 Mar;48(3):274-84. doi: 10.3109/00365521.2012.758769. Epub 2013 Jan 16.