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

Stanford University

Status: Completed

Conditions: Gastroparesis

Treatments: Drug: sapropterin dihydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01135186

SU-03252010-5462

Details and patient eligibility

About

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

Full 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).

Enrollment: 9 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Sapropterin

Other group

Description:

open label study of sapropterin dihydrochloride

Treatment:

Drug: sapropterin dihydrochloride