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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharma USA
ClinicalTrials.gov Identifier:
NCT00050882
First received: December 29, 2002
Last updated: June 23, 2005
Last verified: February 2004

December 29, 2002
June 23, 2005
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Complete list of historical versions of study NCT00050882 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
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.

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Interventional
Phase 2
Primary Purpose: Treatment
Gastroparesis
Drug: GM-611
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050882
GM-611-05
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Chugai Pharma USA
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Chugai Pharma USA
February 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP