Idiopathic gastroparesis
Conditions
Interventions
Intrapyloric injection of botulinum toxin type A 200 IU single injection or placebo single injection.
Scintigraphy for solid/liquid gastric emptying (before and after treatment).
Gastroparesis Cardi
Sponsors
Leiden University Medical Center (LUMC), Department of Gastroenterology & Hepatology
Eligibility
Inclusion criteria
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); 2. Delayed gastric emptying for solids at Visit 1b (eligibility; week -1) as measured with scintigraphy: a. 2h retention ≥ 60%; b. 4h retention ≥ 10%; 3. Absence of an obstructing structural lesion in the stomach or small intestine at prior diagnostic gastrointestinal endoscopy (performed within the previous 5 years) or judged absent by the responsible physician; 4. Patients, both male and female, must use adequate means of birth control during the study; 5. Patients must provide written informed consent prior to any study procedures being performed; 6. Patients aged between 18 and 70 years inclusive; 7. Patients (in the opinion of the investigator) must be able to understand the study and comply with the study requirements.
Exclusion criteria
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; 2. Presence of an obstructing structural lesion in the stomach or small intestine if observed during treatment gastrointestinal endoscopy (visit 2, randomization; week 0); 3. Patients taking drugs that interfere with the effect of botulinum toxin type A; 4. Patients previously treated with intrapyloric injection of botulinum toxin type A; 5. Females who are pregnant or lactating; 6. Patients with diabetes mellitus; 7. Patients with delayed gastric emptying due to systemic disorders, e.g. SLE, sclerodermia, hypothyroidism; 8. Patients with disorders of neuromuscular transmission, e.g. myasthenia gravis and Eaton-Lambert syndrome; 9. Patients with abdominal surgery in their medical history, except (laparoscopic) appendectomy, (laparoscopic) cholecystectomy and/or hysterectomy; 10. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric emptying for solids. 1. Half-emptying time at visit 4 (follow-up; week 6) compared to Visit 1b (eligibility; week -1); 2. Emptying rate per hour at visit 4 (follow-up; week 6) compared to Visit 1b (eligibility; week -1); 3. One, two and four hour meal retention at visit 4 (follow-up; week 6) compared to Visit 1b (eligibility; week -1). Gastroparesis Cardinal Symptom Index (GCSI) outcome; 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); 5. Mean GCSI score during follow-up (week 0-12) compared to mean GCSI score during eligibility and randomization (week -1-0). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gastric emptying for liquids; retention of liquid phase at 15, 30, 45, 60, 75, 90, 105 and 120 min; 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; 3. Psychometric assessment and patient perception of gastrointestinal endoscopy. | — |
Contacts
Public ContactJ.J.L. Haans
Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology, C-04-P room 192, P.O. Box 9600
Outcome results
None listed