A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

NCT00641602 | Completed Phase 4

• 2 other identifiers: 322D9612L00046
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole

Conditions

Erosive Esophagitis

Keywords

Erosive Esophagitis; Nexium; Heartburn

Outcome Measures

Primary Outcomes (1)

• To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.

  Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)

Secondary Outcomes (3)

• 1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.

  Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)

• 1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.

  Dairy card to be completed by patient daily

• To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.

  Adverse event collection on an ongoing basis

Study Arms (2)

1

EXPERIMENTAL

Nexium

Drug: Esomeprazole

2

ACTIVE COMPARATOR

Prevacid

Drug: Lansoprazole

Interventions

Esomeprazole DRUG

40mg once daily

Also known as: Nexium

1

Lansoprazole DRUG

30mg once daily

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 Erosive Esophagitis within 1 week prior to starting 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 24, 2008
• Study Start: December 1, 2002
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: March 26, 2009

Record last verified: 2009-03