A randomized, double-blind, placebo-controlled, multicenter trial to evaluate the clinical efficacy of a single intrapyloric injection of botulinum toxin type A (Botox®) in patients with Idiopathic Gastroparesis. The BIG study.
Completed
- Conditions
- Idiopathic gastroparesis
- Registration Number
- NL-OMON20470
- Lead Sponsor
- eiden University Medical Center (LUMC), Department of Gastroenterology & Hepatology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
Patients are eligible to participate in this study if all of the following criteria are met:
1. Presence of clinical symptoms associated with idiopathic gastroparesis; nausea, vomiting, early satiety, postprandial fullness and a GCSI score ≥ 1 at Visit 1b (eligibility; week -1);
Exclusion Criteria
Patients are excluded from the study if any of the following criteria are met:
1. Patients with predominant abdominal pain/discomfort in the opinion of the investigator;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastric emptying for solids.<br /><br>1. Half-emptying time at visit 4 (follow-up; week 6) compared to Visit 1b (eligibility; week -1);<br /><br>2. Emptying rate per hour at visit 4 (follow-up; week 6) compared to Visit 1b (eligibility; week -1);<br /><br>3. One, two and four hour meal retention at visit 4 (follow-up; week 6) compared to Visit 1b (eligibility; week -1). <br /><br>Gastroparesis Cardinal Symptom Index (GCSI) outcome;<br /><br>4. Total GCSI score at visit 3, 4, 5 and 6 (follow-up; week 3, 6, 9 and 12) compared to visit 2 (randomization; week 0);<br /><br>5. Mean GCSI score during follow-up (week 0-12) compared to mean GCSI score during eligibility and randomization (week -1-0).
- Secondary Outcome Measures
Name Time Method 1. Gastric emptying for liquids; retention of liquid phase at 15, 30, 45, 60, 75, 90, 105 and 120 min;<br /><br>2. Quality of Life as measured with the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL), the RAND-36 and EQ-5D questionnaires;<br /><br>3. Psychometric assessment and patient perception of gastrointestinal endoscopy.