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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 28, 2007 | ||||
| Last Updated Date | April 21, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH > 4.0) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00442208 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate the effect of different dosing times of PN 200 on the pharmacokinetic properties of omeprazole | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers | ||||
| Official Title ICMJE | |||||
| Brief Summary | Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5. |
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| Detailed Description | This study is designed to evaluate the effect of different dosing times of PN 200 relative to food on the intragastric pH profile of PN 200. PN 200 contains immediate release omeprazole, which may be subject to acid degradation in the stomach. Food is known to have a buffering effect on acid and therefore may result in less degradation of immediate release omeprazole. Alternatively, food may decrease the absorption of omeprazole in the duodenum. The relative magnitude of these effects is unknown. The data from this study will aid in choosing the optimal timing of PN dosing relative to food in future studies. The study is not blinded because the primary endpoint (intragastric pH) is a physiological variable not believed to be readily influenced by conscious or subconscious subject control. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: PN 200 | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 24 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00442208 | ||||
| Responsible Party | David Taylor, Pozen Inc. | ||||
| Study ID Numbers ICMJE | PN200-105 | ||||
| Study Sponsor ICMJE | Pozen | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Pozen | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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