Clinical trial NCT00625274: A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn
Upper Abdominal Pain
Nausea
Acid Regurgitation
Keywords: Nexium
esomeprazole
lansoprazole
pantoprazole
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study looks at controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs).


Eligibility criteria: Inclusion Criteria:

* A medical diagnosis of a condition that requires daily Nonsteroidal Anti-Inflammatory Drugs (NSAID) treatment for at least 5 days per week for 1 month prior to entering the study and during the study.
* Some patients will need to undergo an upper endoscopy at screening.

Exclusion Criteria:

* Signs of clinically significant (GI) bleeding (e.g., melena, frank hematochezia) at the time of the baseline EGD or within 3 days prior to randomization.
* History of gastric or esophageal surgery (including but not limited to Nissen fundoplication, bariatric surgery (e.g. gastric stapling or Roux-En-Y gastric bypass), vagotomy, or Billroth operation).
* Many further exclusion criteria, please refer to the investigator site.

Primary outcomes:
measure: To compare the pharmacodynamic efficacy in controlling intragastric pH (percent time pH > 4.0) following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in pat
timeFrame: Screening, assessments every 2 weeks.
Secondary outcomes:
measure: To compare nocturnal intragastric acid control in NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg or pantoprazole 40 mg once daily.
timeFrame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
measure: To compare intragastric acid control utilizing thresholds other than pH 4.0 among NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg once daily.
timeFrame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
measure: To compare the mean hourly cumulative integrated gastric acidity during the 24-hour monitoring period on Day 5 among NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30mg and pantoprazole 40 mg once daily.
timeFrame: 24-hour monitoring period
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References: