Trial Search Results

Impact of KUVANĀ® on Gastric Relaxation in Women With Diabetic Gastroparesis.

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: sapropterin dihydrochloride

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nighat j Ullah
650-721-7216
Recruiting