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AZD0865

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,400

FDA Designations

No designations recorded

Clinical trial landscape

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 in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes AZD0865?

AZD0865 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical trials for the treatment of gastroesophageal reflux disease.

What phase is AZD0865 in?

AZD0865 is in Phase 2 clinical development. It has completed two Phase 2b dose-finding studies in patients with GERD, one with erosive esophagitis and one without erosive esophagitis. The drug remains investigational and has not been approved.

What clinical trials is AZD0865 in?

AZD0865 has completed two Phase 2b clinical trials. NCT00206245 studied the drug in GERD patients with erosive esophagitis, and NCT00206284 studied it in GERD patients without erosive esophagitis. Both trials were randomized, double-blind, and enrolled a total of 1400 participants across multiple countries.

How does AZD0865 work?

AZD0865 is a small molecule designed to treat gastroesophageal reflux disease by reducing gastric acid secretion. It is being investigated for its ability to heal erosive esophagitis and relieve symptoms in patients with non-erosive reflux disease, though its specific molecular target has not been disclosed.