A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis
Public ClinicalTrials.gov record NCT02210000. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of 12 Weeks of Once-daily Dosing of the Oral Motilin Receptor Agonist Camicinal, on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a randomized, double-blind, placebo controlled trial designed to confirm the symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1 and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine if a low-dose of camicinal (25 milligram\[mg\]) for 12 weeks of repeat administration improves gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who have documented abnormally slow gastric emptying and have symptoms consistent with gastroparesis. Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a 2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety follow-up visit.
Study identification
- NCT ID
- NCT02210000
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 114 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 26, 2014
- Primary completion
- Aug 23, 2015
- Completion
- Aug 23, 2015
- Last update posted
- Dec 10, 2017
2014 – 2015
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Chandler | Arizona | 85224 | — |
| GSK Investigational Site | Long Beach | California | 90807 | — |
| GSK Investigational Site | Northridge | California | 91325 | — |
| GSK Investigational Site | Hialeah | Florida | 33016 | — |
| GSK Investigational Site | Inverness | Florida | 34452 | — |
| GSK Investigational Site | Miami | Florida | 33183 | — |
| GSK Investigational Site | Port Orange | Florida | 32127 | — |
| GSK Investigational Site | Atlanta | Georgia | 30312 | — |
| GSK Investigational Site | Marietta | Georgia | 30060 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | — |
| GSK Investigational Site | Towson | Maryland | 21204 | — |
| GSK Investigational Site | Boston | Massachusetts | 02114 | — |
| GSK Investigational Site | Boston | Massachusetts | 02215 | — |
| GSK Investigational Site | Flint | Michigan | 48504 | — |
| GSK Investigational Site | Wyoming | Michigan | 49519 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89123 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89128 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | — |
| GSK Investigational Site | Poughkeepsie | New York | 12601 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27403 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Cleveland | Ohio | 44109 | — |
| GSK Investigational Site | Dayton | Ohio | 45439 | — |
| GSK Investigational Site | Mentor | Ohio | 44060 | — |
| GSK Investigational Site | Greenville | South Carolina | 29615 | — |
| GSK Investigational Site | Rapid City | South Dakota | 57702 | — |
| GSK Investigational Site | Bristol | Tennessee | 37620 | — |
| GSK Investigational Site | Chattanooga | Tennessee | 37421 | — |
| GSK Investigational Site | Germantown | Tennessee | 38138 | — |
| GSK Investigational Site | Arlington | Texas | 76014 | — |
| GSK Investigational Site | Austin | Texas | 78758 | — |
| GSK Investigational Site | Spring | Texas | 77379 | — |
| GSK Investigational Site | Bountiful | Utah | 84010 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02210000, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2017 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02210000 live on ClinicalTrials.gov.