A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving… (NCT00464308) | Clinical Trial Compass
CompletedPhase 4
A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg
Australia1,392 participantsStarted 2006-11
Plain-language summary
The primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Heartburn (defined as a feeling of burning or pain, rising from the epigastrium or lower part of the chest up towards the neck) with or without regurgitation
* Patients must have had episodes of heartburn with or without regurgitation for 3 months or longer, and for \>= 3 days in the 7 days prior to randomisation
* Able to understand and complete questionnaires, able to give written informed consent, and have access to a telephone
Exclusion Criteria:
* Patients requiring endoscopy within 4 weeks of randomisation or with gastrointestinal symptoms that, in the opinion of the investigator, require further investigation prior to or coincident with initiation of PPI therapy which would include, but are not limited to, alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia and epigastric mass
* Significant gastrointestinal obstruction, major gastric or oesophageal surgery (excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric stenosis, extra-oesophageal manifestations of reflux disease
* Patients with Barrett's oesophagus (\>3cm), Zollinger-Ellison Syndrome, scleroderma, malignancy (other than non-melanoma skin cancers) present within the last 5 years, hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant condition that, in the opinion of the investigator, could interfere with the patients participation or compliance in the study such as p…
What they're measuring
1
The Number of Patients With Complete Resolution of Heartburn by Week 4
Timeframe: week 4 of treatment
2
The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4
Timeframe: 4 weeks
3
The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4
Timeframe: 4 weeks
4
The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4