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Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis

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ClinicalTrials.gov Identifier: NCT00050882
Recruitment Status : Completed
First Posted : December 31, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Chugai Pharma USA

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Gastroparesis Drug: GM-611 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050882


  Show 67 Study Locations
Sponsors and Collaborators
Chugai Pharma USA
More Information
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ClinicalTrials.gov Identifier: NCT00050882     History of Changes
Other Study ID Numbers: GM-611-05
First Posted: December 31, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2004

Keywords provided by Chugai Pharma USA:
GM-611
Diabetic gastroparesis
Bloating
Delayed gastric emptying
Mitemcinal

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Paralysis
Neurologic Manifestations
Signs and Symptoms