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.
| ISRCTN | ISRCTN32422510 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32422510 |
| Secondary identifying numbers | P05.170 |
- Submission date
- 09/06/2006
- Registration date
- 09/06/2006
- Last edited
- 09/06/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.J.L. Haans
Scientific
Scientific
Leiden University Medical Center (LUMC)
Department of Gastroenterology and Hepatology C-04-P
Room 192
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5261104 |
|---|---|
| J.J.L.Haans@lumc.nl |
Study information
| Study design | A randomized, double-blind, placebo-controlled, multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | BIG study |
| Study objectives | Several open-label pilot studies have shown a promising effect of intrapyloric botulinum toxin injection on symptoms in severe gastroparesis. However, data from randomized, double-blind, placebo-controlled studies are not yet available. We intend to evaluate the clinical efficacy of a single intrapyloric injection of botulinum toxin type A in patients with idiopathic gastroparesis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Idiopathic gastroparesis |
| Intervention | 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 cardinal symptom index questionnaire Quality of life (QOL) questionnaires Psychometric assessment and patient perception questionnaires |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum toxin |
| Primary outcome measure | 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 10) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2006 |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48 |
| Key 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 Gastroparesis Cardinal Symptom Index (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%; and/or 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 |
| Key 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. systemic lupus erythematosus (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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology (The Netherlands)
University/education
University/education
P.O. Box 9600
Leiden
2300 RC
Netherlands
"ROR" |
https://ror.org/05xvt9f17 |
|---|
Funders
Funder type
University/education
Leiden University Medical Center (LUMC) Department of Gastroenterology and Hepatology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
