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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00625274

Enrollment

100

Registered

2008-02-28

Start date

2004-06-30

Completion date

2004-11-30

Last updated

2008-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid Regurgitation, Heartburn, Nausea, Upper Abdominal Pain

Keywords

Nexium, esomeprazole, lansoprazole, pantoprazole, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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).

Interventions

DRUGEsomeprazole

40mg Oral

DRUGLansoprazole

30mg Oral

DRUGPantoprazole

40mg Oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	Screening, assessments every 2 weeks.

Secondary

Measure	Time frame
To compare nocturnal intragastric acid control in NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg or pantoprazole 40 mg once daily.	Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
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.	Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
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.	24-hour monitoring period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026