Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

NCT00644735 | Completed Phase 4

• 2 other identifiers: 325D9612L00048
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).

Conditions

Erosive Esophagitis

Keywords

Erosive Esophagitis; Nexium; Esomeprazole; Lansoprazole; Heartburn

Outcome Measures

Primary Outcomes (1)

• To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).

  Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Secondary Outcomes (3)

• To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.

  Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

• The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.

  patients will undergo an endoscopy at Months 3 and 6

• To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.

  Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Study Arms (2)

1

EXPERIMENTAL

Nexium

Drug: Esomeprazole

2

ACTIVE COMPARATOR

Prevacid

Drug: Lansoprazole

Interventions

Esomeprazole DRUG

Also known as: Nexium

1

Lansoprazole DRUG

Also known as: Prevacid

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline
• Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before entering the study.

You may not qualify if:

• Any signs of gastrointestinal bleeding at the time of the starting the study.
• Any previous gastric or esophageal surgery.
• Various gastrointestinal diseases as listed in the protocol.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Heartburn

Interventions

Esomeprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 27, 2008
• Study Start: December 1, 2002
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: March 26, 2009

Record last verified: 2009-03