Try our beta test site

The Purpose of This Pilot Study is to Assess the Impact of KUVAN® (Sapropterin Dihydrochloride) on Gastric Relaxation in Women With Diabetic Gastroparesis.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Stanford University.
Recruitment status was:  Recruiting
Information provided by:
Stanford University Identifier:
First received: May 28, 2010
Last updated: June 3, 2010
Last verified: June 2010
Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)

Condition Intervention
Drug: sapropterin dihydrochloride

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Kuvan® (Sapropterin Dihydrochloride) for Improving Gastric Accommodation in Women With Diabetic Gastroparesis (KIGA-DG)

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Gastric accommodation [ Time Frame: Change in total volume consumed during the satiety test from baseline to end of treatment. ]

Secondary Outcome Measures:
  • secondary outcome measures will include improvement in symptom severity. [ Time Frame: Improvement in symtoms after 4 weeks of Kuvan 10mg/kg and 4 weeks of Kuvan 20 mg/kg. ]
  • secondary outcome measures will include improvement in quality of life. [ Time Frame: Improvement in quality of life after 4 weeks of Kuvan 10mg/kg and 4 weeks of Kuvan 20 mg/kg ]
  • secondary outcome measures will include improvement in gastric emptying. [ Time Frame: Improvement in gastric emptying after 4 weeks of Kuvan 10mg/kg and 4 weeks of Kuvan 20 mg/kg ]

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:
Patients are invited to participate in a research study of Kuvan® (sapropterin dihydrochloride). We hope to learn whether treatment with Kuvan® is safe and effective in improving the ability of the stomach to relax after eating and improving the symptoms of diabetic gastroparesis. Women are selected as a possible participant in this study because they have diabetes and moderate to severe gastroparesis (meaning stomach empties slowly).

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:Inclusion Criteria

Patients with moderate to severe symptoms of diabetic gastroparesis will be studied (GCSI >21). Patients should not have post-surgical gastroparesis or dyspeptic symptoms with normal gastric emptying. In order to qualify for inclusion in the trial, patients must satisfy the following inclusion criteria:

  1. Diagnosis of diabetes mellitus > 5 years requiring medical therapy
  2. Female gender
  3. Ages 18-65 years
  4. Documentation of delayed gastric emptying on gastric emptying scintigraphy (within 2 years of enrollment)
  5. Symptoms of gastroparesis for at least 6 months with Gastroparesis Cardinal Symptom Index (GCSI) score > 21 indicating moderate to severe symptoms
  6. Recent negative upper endoscopy or upper GI series within 2 years of enrollment (no evidence of mechanical obstruction or peptic ulcer disease)

Exclusion Criteria:Exclusion Criteria

Patients who satisfy any of the following exclusion criteria will be ineligible for enrollment in the study:

  1. Diabetes diagnosed < 5 years prior to the study
  2. Male gender
  3. Normal gastric emptying
  4. Gastroparesis from post-surgical etiologies
  5. Another active disorder, which could explain symptoms in the opinion of the investigator
  6. Pregnancy
  7. History of significant cardiac arrhythmias and/or prolonged QTc
  8. Daily use of narcotic analgesics for abdominal pain
  9. Contraindications to gastric emptying breath test: patients with a known allergy to egg, wheat, or algae.
  10. Underlying seizure disorder
  11. Known history of cardiac ischemia
  12. Recent clinically significant gastrointestinal bleeding
  13. Patients taking Levodopa
  14. Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
  15. Failure to give informed consent
  16. Surgery for placement of a gastric stimulator within the past 6 months (patients > 6 months post-op with persistent symptoms and delayed gastric emptying are eligible).
  17. A normal upper endoscopy not performed within 2 year of study entry.
  18. Patients taking phosphodiesterase inhibitors such as sildenafil, vardenafil, tadalafil
  19. Patients with renal impairment (i.e. Creatinine > 2.5 mg/dL)
  20. Patients with hepatic dysfunction (i.e. ALT and AST values > 2.5x ULN and T. bilirubin > 1.5x ULN)
  21. Patients with uncontrolled diabetes, such as HbA1c > 10 mg/dl at screening/baseline will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01135186

Contact: Nighat j Ullah (650) 721-7216

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Nighat j Ullah    650-721-7216   
Principal Investigator: Pankaj Jay Pasricha         
Sub-Investigator: Dr. Linda Nguyen         
Sponsors and Collaborators
Stanford University
Sub-Investigator: Dr. Linda Nguyen Stanford University
Principal Investigator: Pankaj Jay Pasricha Stanford University
  More Information

Responsible Party: Pankaj Jay Pasricha, Stanford University School of Medicine Identifier: NCT01135186     History of Changes
Other Study ID Numbers: SU-03252010-5462
Study First Received: May 28, 2010
Last Updated: June 3, 2010

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents processed this record on March 24, 2017