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AZD0865

Phase 2

GERD With Erosive Esophagitis | Small molecule | Gastrointestinal |AstraZeneca PLC|Trials Updated: Jan 4, 2013

AZD0865 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment2,800

FDA Designations

No designations recorded

AZD0865 clinical trials

AZD0865 · 2 trials · 2 indications

Phase 2 2
NCT00206245A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.GERD With Erosive Esophagitis
COMPLETED1,400 Analytics
NCT00206284A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.GERD Without Erosive Esophagitis
COMPLETED1,400 Analytics
PHASE2COMPLETED
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.
GERD With Erosive EsophagitisUnlock trial analytics
PHASE2COMPLETED
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
GERD Without Erosive EsophagitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Healing of erosive esophagitis at 4 weeks.
Time to sustained absence of patient-reported heartburn.

Secondary Endpoints

Healing of erosive esophagitis at 2 and 8 weeks.
The Quality of Life in Reflux and Dyspepsia (QOLRAD).
Patient-reported symptoms.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AZD0865DRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites202

Inclusion Criteria: * Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone. * Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1. *...

Countries:United StatesCanadaDenmarkFinlandFranceGermanyItalyNorwaySwedenUnited Kingdom
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Frequently asked questions about AZD0865

What is AZD0865 used for?

AZD0865 is an investigational small molecule being developed for gastroesophageal reflux disease (GERD), specifically for GERD with erosive esophagitis and GERD without erosive esophagitis. It is a gastrointestinal therapeutic currently in Phase 2 clinical development.

Who makes AZD0865?

AZD0865 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is in Phase 2 clinical development for the treatment of GERD with and without erosive esophagitis.

What phase is AZD0865 in?

AZD0865 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. Two Phase 2 trials have been completed for the drug.

What clinical trials is AZD0865 in?

AZD0865 has been studied in two completed Phase 2 clinical trials: NCT00206245, a dose-finding study in patients with GERD and erosive esophagitis, and NCT00206284, a dose-finding study in patients with GERD without erosive esophagitis. Both trials enrolled 1400 participants.

Is AZD0865 the same as esomeprazole?

No, AZD0865 is not the same as esomeprazole. In clinical trials, AZD0865 was studied in comparison with esomeprazole, which is an approved proton pump inhibitor used as an active control. AZD0865 is a separate investigational compound being developed by AstraZeneca.