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).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: November 2004

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 40mg Oral
• Drug: Lansoprazole
  • 30mg Oral
• Drug: Pantoprazole
  • 40mg Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Oral
• Experimental: 2
  • Oral
• Experimental: 3
  • Oral

Primary Measures

• 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
  • Time Frame: Screening, assessments every 2 weeks.
    Safety Issue?: No

Secondary Measures

• To compare nocturnal intragastric acid control in NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg or pantoprazole 40 mg once daily.
  • Time Frame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
    Safety Issue?: No
• 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.
  • Time Frame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
    Safety Issue?: No
• 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.
  • Time Frame: 24-hour monitoring period
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00625274

Study ID Number: D9612L00063

ClinicalTrials.gov Identifier: NCT00625274

Health Authority: United States: Food and Drug Administration