| February 20, 2008 |
| February 27, 2008 |
| June 2004 |
| November 2004 (final data collection date for primary outcome 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 [ Time Frame: Screening, assessments every 2 weeks. ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00625274 on ClinicalTrials.gov Archive Site |
- 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. ] [ Designated as 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. ] [ Designated as 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 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| 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 |
| |
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). |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Crossover Assignment, Pharmacodynamics Study |
- Heartburn
- Upper Abdominal Pain
- Nausea
- Acid Regurgitation
|
- Drug: Esomeprazole
- Drug: Lansoprazole
- Drug: Pantoprazole
|
| Experimental: Oral |
| |
| |
| Completed |
| 100 |
| November 2004 |
| November 2004 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 60 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00625274 |
| Tore Lind, MD - Nexium Medical Science Director, AstraZeneca |
| D9612L00063 |
| AstraZeneca |
|
| Study Director: |
Paula Fernstrom |
Nexium Global Product Director, AstraZeneca |
|
|
| AstraZeneca |
| February 2008 |
