N/A
N=9
Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.
Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT01135186 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Mar 2017
Primary outcome: Primary: Gastric Accommodation — 322.22; 402.78; 450.63 ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sapropterin dihydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastric Accommodation |
322.22; 402.78; 450.63 | — |
| SECONDARY Secondary Outcome Measures Will Include Change in Symptom Severity. |
32.00; 23.25; 23.67 | — |
| SECONDARY Secondary Outcome Measures Will Include Change in Quality of Life. |
91.22; 61.29; 60.50 | — |
| SECONDARY Secondary Outcome Measures Will Include Change in Symptom Severity as Measured by the Patient Assessment of Gastrointestinal Disorder-Symptom Severity Index Disorders Symptom Severity Index (PAGI-SYM) |
54.89; 41.50; 34.50 | — |
Summary
Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)
Eligibility 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:
- Diagnosis of diabetes mellitus > 5 years requiring medical therapy
- Female gender
- Ages 18-65 years
- Documentation of delayed gastric emptying on gastric emptying scintigraphy (within 2 years of enrollment)
- Symptoms of gastroparesis for at least 6 months with Gastroparesis Cardinal Symptom Index (GCSI) score > 21 indicating moderate to severe symptoms
- 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:
- Diabetes diagnosed 6 months post-op with persistent symptoms and delayed gastric emptying are eligible).
- A normal upper endoscopy not performed within 2 year of study entry.
- Patients taking phosphodiesterase inhibitors such as sildenafil, vardenafil, tadalafil
- Patients with renal impairment (i.e. Creatinine > 2.5 mg/dL)
- Patients with hepatic dysfunction (i.e. ALT and AST values > 2.5x ULN and T. bilirubin > 1.5x ULN)
- Patients with uncontrolled diabetes, such as HbA1c > 10 mg/dl at screening/baseline will be excluded.
Data sourced from ClinicalTrials.gov (NCT01135186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.