Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis

PHASE2TerminatedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Gastroparesis
Interventions
DRUG

Erythromycin

200mg/5ml elixir administered orally three times a day half an hour prior to meals.

DRUG

Azithromycin

The dose of Azithromycin given was determined based on the following study on 10 healthy subjects. In random order, each of ten healthy subjects underwent OBT studies following administration of AZI, at doses of 50mg, 100mg, and 133mg. The T½ and Tlag was then compared for the three doses by a randomized block analysis using Analysis of Variance followed by Tukey's multiple comparison. Results: The T½ for each of the respective doses of AZI (50mg, 100mg, and 133mg) was 129 ± 27, 128 ± 31, and 128 ± 16 minutes (p = 0.98). This data suggested that AZI at doses of 50mg, 100mg and 133 mg have fairly similar activity in its effects on gastric emptying in healthy subjects. Based on this analysis , we decided to use a dose of 50 mg/5 ml for administered TID prior to meals.

Trial Locations (1)

32610

University of Florida, Gainesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Metabolic Solutions Inc.

INDUSTRY

lead

University of Florida

OTHER

NCT01323582 - Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis | Biotech Hunter | Biotech Hunter