Abstract | OBJECTIVES: METHODS: We conducted a multicenter, randomized, double-blind, crossover study comparing single doses of AP with placebo. Different patients were enrolled at each of four escalating AP doses: 10, 20, 40, and 60 mg. Enrolled patients had GERD symptoms at least three times a week and 20 reflux episodes on impedance/pH monitoring over a period of 2 h. During study visits separated by periods of 3-7 days, patients received single doses of AP or placebo, followed by high-fat meals 2 and 6 h after treatment. The primary end point was the number of reflux episodes over 12 h after treatment. RESULTS: A total of 50 patients were treated; efficacy analysis included 44 patients who received both AP and placebo and had technically satisfactory impedance/pH data. For the combined data from all dose cohorts, there was a statistically significant (P=0.01) decrease in reflux episodes over 12 h after treatment with AP compared with placebo. The mean (s.d.) number of reflux episodes over 12 h after AP treatment was 50.5 (27.2), with a mean reduction of 10.4 (23.9) episodes (17%) compared with placebo, for which a mean (s.d.) number of 60.9 (35.3) episodes was observed. Heartburn events associated with reflux were reduced during treatment with AP compared with placebo. AP seemed to be the most efficacious in the 60-mg dose group, and was well tolerated at all dose levels. CONCLUSIONS: AP decreased reflux and associated symptoms with good tolerability in patients with GERD.
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Authors | Lauren B Gerson, F Jacob Huff, Amine Hila, William K Hirota, Sandra Reilley, Amit Agrawal, Ritu Lal, Wendy Luo, Donald Castell |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 105
Issue 6
Pg. 1266-75
(Jun 2010)
ISSN: 1572-0241 [Electronic] United States |
PMID | 20040914
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Gastrointestinal Agents
- Prodrugs
- Baclofen
- arbaclofen placarbil
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Topics |
- Adult
- Baclofen
(analogs & derivatives)
- Cross-Over Studies
- Dose-Response Relationship, Drug
- Double-Blind Method
- Esophageal pH Monitoring
- Female
- Gastroesophageal Reflux
(drug therapy)
- Gastrointestinal Agents
(therapeutic use)
- Heartburn
(drug therapy)
- Humans
- Male
- Manometry
- Middle Aged
- Prodrugs
(therapeutic use)
- Young Adult
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