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 because the information has not been verified recently.
Verified June 2010 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01135186
First received: May 28, 2010
Last updated: June 3, 2010
Last verified: June 2010
  Purpose

Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)


Condition Intervention
Gastroparesis
Drug: sapropterin dihydrochloride

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135186

Contacts
Contact: Nighat j Ullah (650) 721-7216 nullah@stanford.edu

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

Publications:
Responsible Party: Pankaj Jay Pasricha, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01135186     History of Changes
Other Study ID Numbers: SU-03252010-5462
Study First Received: May 28, 2010
Last Updated: June 3, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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 17, 2014