The Purpose of This Pilot Study is to Assess the Impact of KUVAN® (Sapropterin Dihydrochloride) on Gastric Relaxation in Women With Diabetic Gastroparesis.
Recruitment status was Recruiting
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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) |
- 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 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) |
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 |
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 < 5 years prior to the study
- Male gender
- Normal gastric emptying
- Gastroparesis from post-surgical etiologies
- Another active disorder, which could explain symptoms in the opinion of the investigator
- Pregnancy
- History of significant cardiac arrhythmias and/or prolonged QTc
- Daily use of narcotic analgesics for abdominal pain
- Contraindications to gastric emptying breath test: patients with a known allergy to egg, wheat, or algae.
- Underlying seizure disorder
- Known history of cardiac ischemia
- Recent clinically significant gastrointestinal bleeding
- Patients taking Levodopa
- Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- Failure to give informed consent
- 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).
- 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.
Contacts and Locations| Contact: Nighat j Ullah | (650) 721-7216 | nullah@stanford.edu |
| 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 | |
| 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 June 18, 2013