drugset / Trial / NCT00740324
Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.
Timeline
- Start
- 2008-08
- Primary completion
- 2009-03
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glucagon | Peptide | 1 mg | — |
| Subject | Hyoscine butylbromide | Unknown | 20 mg | — |
| Comparator | NPO-11 | Unknown | — | Other |
Indications
No indication recorded.