GastroparesisPhase 2NCT00050882
Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
A Phase 2 study testing GM-611 in people with Gastroparesis, run by Chugai Pharma USA at 67 sites in United States.
Trial summary
This study is intended to evaluate the potential to relieve the symptoms associated with gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg, 10mg or placebo to type I or II diabetics who require insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- GM-611
- How many people
- Not given
- Where
- 67 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Inclusion Criteria - Others Stipulated within the Protocol
- The study physician must assure you have/are:
- Must be at least 18 years of age and have diabetes mellitus requiring insulin, which may be in addition to oral anti-diabetic agents.
- At least a three month history of the symptoms of gastroparesis that may include: early satiety (feeling full soon after beginning a meal), persistent fullness (long after eating), abdominal distention or bloating, nausea and vomiting. - No evidence of mechanical gastric obstruction, or other gastric problems since the onset of gastroparesis symptoms.
- You may be required to under go a Gastric Emptying Test (GET) procedure.
- You must be willing and able to maintain a daily telephone diary and consent to participate in this study.
Who cannot join
- Major Exclusion Criteria - Others Stipulated within the Protocol
- The study physician must assure you do not have/are not:
- Prior history of gastric surgery, excluding reflux surgery.
- Inability to withdraw from current prokinetic agents (e.g., metoclopramide, erythromycin, others) prior to, and during the study.
- Unstable current medical or surgical condition, or a recent history of frequent hospitalizations.
- A history of: HIV, recurring infection affecting the gastrointestinal track, cirrhosis, acute or chronic liver disease, active pancreatitis, cholecystitis, psychosis, severe depression, Parkinson's disease, myopathy, scleroderma, eating disorder, or organ transplant.
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- Evidence or history of QT-prolongation, or use of drugs that are, or may be associated with QT-prolongation are prohibited.
- May not be pregnant, breast-feeding or not using approved methods of contraception.
- An allergy or intolerance to macrolide antibiotics (e.g., erythromycin).
- Use of any investigational drug within 30 days prior to screening.
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Lovelace Scientific Resources, Inc
Albuquerque, New Mexico, 87108
Pharma Tex Research
Amarillo, Texas
AGMG Clinical Research
Anaheim, California, 92801
Center for Diabetes & Endocrinology
Arvada, Colorado, 80002
Emory University School of Medicine
Atlanta, Georgia
Diabetic Care Associates
Binghamton, New York, 13903
Idaho Gastroenterology Associates
Boise, Idaho, 83702
Radiant Research Boise
Boise, Idaho, 83704
Gastroenterology Associates of Manatee, PA
Bradenton, Florida, 34209
Medical University of South Carolina
Charleston, South Carolina, 29425
Hyperion Clinical Research
Charleston, West Virginia, 25301
Carolina Digestive Health Associates
Charlotte, North Carolina, 28211
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Prime Care Clinical Research
Clinton, Oklahoma, 73601
Orange County Clinical Research, Inc
Cypress, California, 90630
Radiant Research-Dallas North
Dallas, Texas, 75231
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262
Henry Ford Hospital
Detroit, Michigan, 48202
Radiant Research
Edina, Minnesota, 55435
Metropolitan Research
Fairfax, Virginia, 22031
Arizona Center for Clinical Research
Glendale, Arizona, 85306
Center for Diabetes & Endocrinology
Grand Rapids, Michigan, 49503
Core Health Services, Inc
Hampton, New Hampshire, 03842
Rocky Mountain Institute of Clinical Research
Idaho Falls, Idaho, 83404
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, 46260
University of Mississippi Medical Center
Jackson, Mississippi, 39216-9941
GI Associates Research
Jackson, Mississippi
Regional Research Institute
Jackson, Tennessee, 38305
University of Kansas Medical Center
Kansas City, Kansas, 66160
Evergreen Diabetes & Endocrinology Medical Group
Kirkland, Washington, 98034
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, 17601
Lovelace Scientific Resources c/o Southwest Medical Associates
Las Vegas, Nevada, 89102
Long Beach VA Medical Center
Long Beach, California, 90822
Research Foundation of America
Los Angeles, California, 90035
Digestive Health Center, University of Louisville
Louisville, Kentucky
University of Wisconsin-Madison
Madison, Wisconsin, 53717-2656
Baptist Diabetes Associates
Miami, Florida, 33176
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207
Anchor Research Center
Naples, Florida, 34102
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Suncoast Clinical Research
New Port Richey, Florida, 34652
BioQuan Research Group
North Miami, Florida, 33161
Advanced Clinical Research, Ltd
North Providence, Rhode Island, 02911
University of Nebraska Health Center
Omaha, Nebraska, 68198-2000
Community Clinical Trials
Orange, California, 92868
Diabetes Control Center
Orangeburg, South Carolina, 29118
Gastroenterology, Ltd.
Peoria, Illinois, 61602
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Temple University Hospital-GI Section
Philadelphia, Pennsylvania, 19140
Lovelace Scientific Resources
Phoenix, Arizona, 85016
Keystone Digestive Disorders Consultants, PC
Pittsburgh, Pennsylvania, 15224
McGuire VA Medical Center
Richmond, Virginia, 23249
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, 61107
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132-2410
Pro-Research Group
San Antonio, Texas, 78224
Diabetes & Glandular Disease Research Associates
San Antonio, Texas, 78229
The Whittier Institute for Diabetes & Endocrinology
San Diego, California, 92037
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
Medical Research Institute
Slidell, Louisiana, 70458
Research Site
Stoneboro, Pennsylvania, 16153
Palm Beach Research Center
West Palm Beach, Florida, 33409
Westlake Medical Research
Westlake Village, California, 91361
Professional Research Network of Kansas
Wichita, Kansas, 67203
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103
About this study
Official title: A 12-Week Study Conducted at Multiple Centers, Blinded to Both the Patient and Doctor, Evaluating for Safety and Effectiveness Two Dosages of an Investigational Agent (GM-611) Versus a Placebo, That Are Randomly Assigned to Patients With Diabetic Gastroparesis
This study is intended to evaluate the potential to relieve the symptoms associated with gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg, 10mg or placebo to type I or II diabetics who require insulin.
Additionally the study will evaluate the safety and tolerability of GM-611 compared to placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic control.
- Conditions
- Gastroparesis
- Being tested
- GM-611
- Keywords
- GM-611, Diabetic gastroparesis, Bloating, Delayed gastric emptying, Mitemcinal
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-611Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Chugai Pharma USA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050882
- Sponsor's protocol ID
- GM-611-05
- Status last verified
- Feb 2004
- First submitted
- 29 Dec 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Study Conducted at Multiple Centers, Blinded to Both the Patient and Doctor, Evaluating for Safety and Effectiveness Two Dosages of an Investigational Agent (GM-611) Versus a Placebo, That Are Randomly Assigned to Patients With Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT00050882
- Acronym / sponsor ID
- GM-611-05
- Conditions
- Gastroparesis
- Keywords
- GM-611, Diabetic gastroparesis, Bloating, Delayed gastric emptying, Mitemcinal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chugai Pharma USAIndustry (pharma, biotech, devices)
- First posted
- 31 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to evaluate the potential to relieve the symptoms associated with gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg, 10mg or placebo to type I or II diabetics who require insulin.
Additionally the study will evaluate the safety and tolerability of GM-611 compared to placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic control.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major Inclusion Criteria - Others Stipulated within the Protocol
- Must be at least 18 years of age and have diabetes mellitus requiring insulin, which may be in addition to oral anti-diabetic agents.
- At least a three month history of the symptoms of gastroparesis that may include: early satiety (feeling full soon after beginning a meal), persistent fullness (long after eating), abdominal distention or bloating, nausea and vomiting. - No evidence of mechanical gastric obstruction, or other gastric problems since the onset of gastroparesis symptoms.
- You may be required to under go a Gastric Emptying Test (GET) procedure.
- You must be willing and able to maintain a daily telephone diary and consent to participate in this study.
Key exclusion criteria (10 listed)
- Major Exclusion Criteria - Others Stipulated within the Protocol
- Prior history of gastric surgery, excluding reflux surgery.
- Inability to withdraw from current prokinetic agents (e.g., metoclopramide, erythromycin, others) prior to, and during the study.
- Unstable current medical or surgical condition, or a recent history of frequent hospitalizations.
- A history of: HIV, recurring infection affecting the gastrointestinal track, cirrhosis, acute or chronic liver disease, active pancreatitis, cholecystitis, psychosis, severe depression, Parkinson's disease, myopathy, scleroderma, eating disorder, or organ transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM-611 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-611 in people with Gastroparesis, run by Chugai Pharma USA at 67 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.