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NCT01262898 · ClinicalTrials.gov registry record · Phase 2
Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis
A Phase 2 study of Gastroparesis, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
- 20
- Study locations
NCT01262898: Completed Phase 2 study of Gastroparesis, sponsored by GlaxoSmithKline.
NCT01262898 is a Phase 2 study of Gastroparesis that has completed, run by GlaxoSmithKline. The registered enrollment target is 79 participants, below the 300-participant average among 44 other Gastroparesis trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01262898, a Phase 2 study of Gastroparesis, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
- 20
- Study locations
Study Summary
GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory findings. Pharmacokinetic parameters were linear and approximately dose proportional over the range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly increased the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout repeated dosing to healthy volunteers for 14-days. The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040 after 28 days of once-daily dosing in Type I and Type II diabetic subjects with gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic effect relationship.
Primary Outcome
Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 28, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GSK962040 (5 mg tablet)
- DRUG GSK962040 (25 mg tablet)
- DRUG GSK962040 (125 mg tablet)
Study Locations (20)
Other
- GSK Investigational Site - Brussels
- GSK Investigational Site - Leuven
- GSK Investigational Site - Uppsala
- GSK Investigational Site - Cambridge
- GSK Investigational Site - Dundee
- GSK Investigational Site - London
Alberta
- GSK Investigational Site - Calgary
- GSK Investigational Site - Edmonton
Ontario
- GSK Investigational Site - Thornhill
- GSK Investigational Site - Toronto
California
- GSK Investigational Site - Concord
Indiana
- GSK Investigational Site - Indianapolis
Maryland
- GSK Investigational Site - Chevy Chase
Massachusetts
- GSK Investigational Site - Boston
New York
- GSK Investigational Site - Great Neck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2011-05-03 |
| Est. Completion | 2013-02-26 |
| Phase | Phase 2 |
What the finished NCT01262898 record still lists
NCT01262898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 300-participant average among 44 other Gastroparesis trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01262898 names 20 study sites across 13 states, led by Other, Alberta, Ontario.
Frequently Asked Questions
What is clinical trial NCT01262898 about?
NCT01262898 is a clinical study titled "Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis". GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater prevalence than placebo, and ...
What is the current status of trial NCT01262898?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2011-05-03. Estimated completion is 2013-02-26.
What conditions does trial NCT01262898 study?
This clinical trial studies the following conditions: Gastroparesis.
What interventions are being tested in trial NCT01262898?
The interventions under investigation include: Placebo (DRUG), GSK962040 (5 mg tablet) (DRUG), GSK962040 (25 mg tablet) (DRUG), GSK962040 (125 mg tablet) (DRUG).
Who is sponsoring clinical trial NCT01262898?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01262898 being conducted?
This trial has 20 study locations across California, Indiana, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01262898's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroparesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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