Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/06/2006
Date assigned
09/06/2006
Last edited
09/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.J.L. Haans

ORCID ID

Contact details

Leiden University Medical Center (LUMC)
Department of Gastroenterology and Hepatology C-04-P
Room 192
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5261104
J.J.L.Haans@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P05.170

Study information

Scientific title

Acronym

BIG study

Study hypothesis

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

Not provided at time of registration

Study design

A randomized, double-blind, placebo-controlled, multicenter trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Botulinum toxin

Primary outcome measures

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 trial start date

01/06/2006

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

01/06/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology (The Netherlands)

Sponsor details

P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Leiden University Medical Center (LUMC) Department of Gastroenterology and Hepatology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes