Clinical trial NCT00206284: A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
Official title: A 4-week, Randomised, Double-blind, Multicentre, Dose-finding Phase IIb Study With AZD0865 25, 50, 75 mg and Esomeprazole 20 mg, Given Orally Once Daily for the Treatment of GERD Without Erosive Esophagitis According to the LA Classification in Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: GERD Without Erosive Esophagitis
Keywords: GERD without erosive esophagitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg). The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.


Eligibility criteria: 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.
* Have an absence of mucosal breaks in the esophagus, as defined by the LA classification, at the visit 1 endoscopy.
* Have provided Informed consent.

Exclusion Criteria:

Subjects with current or historical evidence of the following conditions are excluded from the study:

* Erosive esophagitis.
* Esophageal columnar metaplasia (Barrett's esophagus) of 1.0 cm or greater.
* Esophageal stricture.
* Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
* Systemic Sclerosis (scleroderma).
* Irritable Bowel Syndrome (IBS), i.e. upper abdominal discomfort or pain that in the opinion of the Investigator is likely to be due to IBS or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools.
* Inflammatory bowel disease.
* Zollinger-Ellison syndrome.
* Gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months

Subjects with i) history of significant or ii) current significant or unstable:

* Cardiovascular diseases or cardiac chest pain.
* Cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus.
* Diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable.
* Pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study.
* Malignant disease (except for minor superficial skin disease).
* Generalised bleeding disorders.

Primary outcomes:
measure: Time to sustained absence of patient-reported heartburn.
Secondary outcomes:
measure: The Quality of Life in Reflux and Dyspepsia (QOLRAD).
measure: Patient-reported symptoms.
measure: Investigator-reported symptoms.
measure: Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
measure: pH monitoring.
measure: Histology.
measure: Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).
Other outcomes:
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city: Woking
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Study officials:
References:
citation: Kahrilas PJ, Jonsson A, Denison H, Wernersson B, Hughes N, Howden CW. Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy. Gut. 2014 May;63(5):720-6. doi: 10.1136/gutjnl-2013-304883. Epub 2013 Jul 5.