Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

NSAIDs Clinical Trial

Official title:

Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo and Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241527
• Other study ID #: D9617C00003
• Secondary ID: SH-NEN-0003
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2005
• Last updated: January 21, 2011
• Start date: December 2000
• Est. completion date: September 2002

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: September 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent.

• 18 years of age, or older.

• Capable of completing the diary card.

• Ability to complete the HRQL questionnaires.

• A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).

• Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)

• Hp negative by UBT, serology or biopsy based test, at visit 1.

Exclusion Criteria:

• Current, or history of, gastric or duodenal ulcer

• Current, or history of, esophageal, gastric or duodenal surgery.

• History of GERD, not associated with NSAID use.

• Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.

• Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.

• Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• NSAIDs
• Upper GI Symptoms

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
Australia	Research Site	Carina Heights	Queensland
Australia	Research Site	Five Dock	New South Wales
Australia	Research Site	Ivanhoe	Victoria
Australia	Research Site	Kippa Ring	Queensland
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Quesnel
Canada	Research Site	Sainte-Foy	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	St. John's
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Windsor	Ontario
Canada	Research Site	Winnipeg	Manitoba
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 5
Italy	Research Site	Bari	BA
Italy	Research Site	Genova	GE
Italy	Research Site	Milano	MI
Italy	Research Site	Napoli
Italy	Research Site	Perugia	PG
Italy	Research Site	Verona
Italy	Research Site	Vicenza	VI
Norway	Research Site	Bærum postterminal
Norway	Research Site	Bergen
Norway	Research Site	Bodø
Norway	Research Site	Gjøvik
Norway	Research Site	Horten
Norway	Research Site	Kristiansand S
Norway	Research Site	Lillehammer
Norway	Research Site	Nesttun
Norway	Research Site	Oslo
Norway	Research Site	Sandvika
Norway	Research Site	Skien
Norway	Research Site	Stavanger
Norway	Research Site	Tromsø
Poland	Research Site	Bydgoszcz
Poland	Research Site	Sopot
Poland	Research Site	Warszawa
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Nové Mesto nad Váhom
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Johannesburg
South Africa	Research Site	Pretoria
Sweden	Research Site	Bredbyn
Sweden	Sweden	Gävle
Sweden	Research Site	Karlskrona
Sweden	Research Site	Kungälv
Sweden	Research Site	Lidköping
Sweden	Research Site	Malmö
Sweden	Research Site	Örnsköldsvik
Sweden	Research Site	Oskarshamn
Sweden	Research Site	Östersund
Sweden	Research Site	Rättvik
Sweden	Research Site	Skövde
Sweden	Research Site	Stockholm
Sweden	Research Site	Trehörningsjö
Sweden	Research Site	Trollhättan
Sweden	Research Site	Varberg
Sweden	Research Site	Värnamo
Sweden	Research Site	Västervik
United Kingdom	Research Site	Ashford
United Kingdom	Research Site	Audley
United Kingdom	Research Site	Bath
United Kingdom	Research Site	Bradford upon Avon
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Crawley
United Kingdom	Research Site	Ely
United Kingdom	Research Site	Folkestone
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Kilmarnock
United Kingdom	Research Site	Leigh
United Kingdom	Research Site	Mansfield
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Pontefract
United Kingdom	Research Site	Reading	Berks
United Kingdom	Research Site	Shrewsbury
United Kingdom	Research Site	Spennymoor	Co. Durham
United Kingdom	Research Site	Stafford
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Trowbridge
United Kingdom	Research Site	Trowbridge	Wiltshire
United Kingdom	Research Site	Tunbridge Wells
United Kingdom	Research Site	Watford
United Kingdom	Research Site	Wigston
United Kingdom	Research Site	Woking
United Kingdom	Research Site	Woking	Surrey
United Kingdom	Research Site	Worsley
United Kingdom	Research Site	Yoxall
United States	Research Site	Bradenton	Florida
United States	Research Site	Butte	Montana
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Coral Gables	Florida
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Edmonds	Washington
United States	Research Site	Elkhart	Indiana
United States	Research Site	Endwell	New York
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Evansville	Indiana
United States	Research Site	Garden Grove	California
United States	Research Site	Greenfield	Wisconsin
United States	Research Site	Hewlett	New York
United States	Research Site	Hollywood	Florida
United States	Research Site	Hollywood	Maryland
United States	Research Site	Jackson	Tennessee
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Nampa	Idaho
United States	Research Site	Newburgh	Indiana
United States	Research Site	Olympia	Washington
United States	Research Site	Orange	California
United States	Research Site	Pasadena	Texas
United States	Research Site	Phoenix	Arizona
United States	Research Site	Princeton	New Jersey
United States	Research Site	St Petersburg	Florida
United States	Research Site	Tallassee	Alabama
United States	Research Site	Tavares	Florida
United States	Research Site	Toms River	New Jersey
United States	Research Site	Waco	Texas
United States	Research Site	Wichita	Kansas
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Zephyr Hills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Italy,  Norway,  Poland,  Slovakia,  South Africa,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the upper GI symptoms (pain, discomfort or
Primary	burning in the upper abdomen), rated on a 7-graded severity scale
Secondary	- Mean change in the upper GI symptom score
Secondary	- The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
Secondary	- Mean upper GI symptom score by day over the duration of the study.
Secondary	- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
Secondary	- Proportions of patients with upper GI symptoms during night, over the duration of the study.
Secondary	- The proportion of patients with resolution or relief of investigator-recorded symptoms of heartburn, acid regurgitation, nausea & upper abdominal bloating at the 2-week, and 4-week visits.
Secondary	- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
Secondary	- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
Secondary	- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
Secondary	-Short Form-36 (SF-36) score at baseline.