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
  Purpose

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 Intervention Phase
Gastroparesis
Drug: GM-611
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Chugai Pharma USA:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050882

  Show 67 Study Locations
Sponsors and Collaborators
Chugai Pharma USA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00050882     History of Changes
Other Study ID Numbers: GM-611-05
Study First Received: December 29, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014