Evaluation Study of a Management Strategy for Gastroesophageal Reflux

Status Completed

Clinical Trial Summary

The aim of this project is to compare the GERD clinical outcomes in patients where a structured pathway using the GerdQ questionnaire is implemented compared with the clinical outcomes of those treated without this implementation.

This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and Sweden). Due to different characteristics regarding the actual management of this disease in the 5 countries, each country had the flexibility to introduce design differences and changes in the study protocol.

Clinical Trial Description

In Norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of GERD is compared to the ordinary clinical pathway consisting of the endoscopic/pH-metry approach in patients referred from primary care to GI specialists.

In Italy, it is a PCP-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with GERD. The implementation consists of training sessions on the clinical pathway with the selected PCPs (Implementation Group).

In Sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having GERD. The participating PCCs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines.

In Austria and Spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on GERD patients . The evaluation study will take place subsequent to a prior implementation of a clinical pathway. The implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of PCCs. The implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00842387
Study type	Observational
Source	AstraZeneca
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	December 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06094062` - Smartphone App-assisted PPI	N/A
Completed	`NCT00481949` - Assessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo	N/A
Completed	`NCT04560595` - Remote Guided Caffeine Reduction	N/A
Recruiting	`NCT01696734` - Domperidone in Treating Patients With Gastrointestinal Disorders	Phase 3
Recruiting	`NCT02105090` - Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy	Phase 4
Completed	`NCT01338077` - Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease	Phase 3
Completed	`NCT01005251` - Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI	Phase 2
Terminated	`NCT00536328` - What is the Predictive Value of the Reflux Impact Scale	N/A
Completed	`NCT00382577` - Efficacy and Safety of Itopride vs Placebo in Heartburn	Phase 3
Completed	`NCT00236197` - E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers	Phase 3
Completed	`NCT00236184` - E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers	Phase 3
Completed	`NCT00236392` - A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD)	Phase 3
Completed	`NCT04153552` - Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn	N/A
Recruiting	`NCT06075082` - The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.	N/A
Completed	`NCT05247333` - Implementation of a Minor Ailment Service in Community Pharmacy Practice	N/A
Recruiting	`NCT02277886` - Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances	Phase 4
Completed	`NCT01249651` - To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole	Phase 4
Completed	`NCT00588939` - Confocal Laser Microscopy in Non Erosive Reflux Disease	N/A
Completed	`NCT00206024` - Acid-Associated Heartburn Symptoms and Dose of Esomeprazole	Phase 4
Recruiting	`NCT05976165` - A Study of Breath Testing for Small Intestinal Bacterial Overgrowth	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms