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Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis
NCT01262898 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01262898
The ClinicalTrials.gov registry entry for NCT01262898 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01262898 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Alberta, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01262898?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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