drugset / Trial / NCT00258193
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
RandomizedParallel-groupDouble-blindTreatment
Summary
* The primary objective of this trial is to compare the dose-ranging pharmacodynamic effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on gastrointestinal transit in patients with C-IBS. * The secondary objectives of this trial are: 1. To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on time to first bowel movement after first drug intake. 2. To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on stool frequency, stool consistency, ease of passage and sensation of incomplete evacuation during the Treatment Period relative to Baseline.
Timeline
- Start
- 2006-01
- Primary completion
- —
- Completion
- 2006-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaclotide | Peptide | 100 ug | Oral |
| Subject | Linaclotide | Peptide | 1000 ug | Oral |