Full results & analysis
Available in the Gosset platform where reported.
01
Overview
Phase 2, randomised, double-blind trial of camicinal in gastroparesis (4 arms), sponsored by GSK. Primary endpoint: Gastric Half Emptying Time at Day 28. Started May 2011; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
GSK962040 (10 mg)
GSK962040 10 mg once daily
GSK962040 (50 mg)
GSK962040 50 mg once daily
GSK962040 (125 mg)
GSK962040 125 mg once daily
Placebo
Matching placebo once daily
03
Who it enrols
Adult patients with Type I or II Diabetes Mellitus and confirmed gastroparesis (delayed gastric emptying and symptoms > 3 months).
04
Endpoints
Primary
Gastric Half Emptying Time
Secondary
Number of Participants With On-treatment Adverse Events and Serious Adverse Events
Change From Baseline in Systolic and Diastolic Blood Pressure
Change From Baseline in Heart Rate
Change From Baseline in Electrocardiography Parameters
Mean Change From Baseline in Clinical Chemistry Parameters
Mean Change From Baseline in Hematology Parameters
Pharmacokinetic Parameters (AUC, Cmax, Tmax, Ct, CL/F, V/F)
Daily Bowel Movement Frequency
05
Results
Primary endpoints met
Beyond the preview
Go deeper on NCT01262898.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01262898.