Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372970
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2006-09-05
Brief Title:
Placebo Controlled Trial of Botulinum Toxin for Gastroparesis
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Randomized Placebo-Controlled Double Blind Study of Botulinum Toxin Versus Placebo for the Treatment of Gastroparesis
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature Botox relaxes the pylorus so that food can empty the stomach more rapidly Lesser quality studies have shown that this treatment works in about 40 of patients and relieves symptoms for up to 3 months This study compares this treatment to placebo saline injection After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection Patients symptoms and gastric emptying are followed for 1 year
Detailed Description:
Patients with gastroparesis or delayed gastric emptying present with early satiety postprandial bloating nausea vomiting and abdominal pain or discomfort1 Gastric emptying is a highly regulated process reflecting the integration of propulsive forces generated by proximal fundic tone and distal antral contractions with the resistance of the pyloric sphincter Antral hypomotility as well as increased gastric outlet resistance due to pyloric dysfunction or pylorospasm appear to be important physiologic disturbances in gastroparesis2-4 Current treatment for gastroparesis employs prokinetic agents that increase antral contractility and accelerate gastric emptying5 Unfortunately prokinetic agents have limited efficacy and trials of these agents have suffered from significant methodological flaws6 Troublesome side effects such as cardiac arrhythmias in the case of cisapride Propulsid Janssen Pharmaceutica and extrapyramidal symptoms and sedation in the case of metoclopramide Reglan AH Robins have limited the usefulness of these agents7 Domperidone may be effective for treating symptoms of gastroparesis however it is unavailable in the US8
Botulinum toxin Botox Allergan is an inhibitor of cholinergic neuromuscular transmission and has been used to treat spastic disorders of both striated and smooth muscles by local injection into affected muscles9 Previous published work from our institution demonstrated that injection of botulinum toxin into the pylorus improved gastric emptying and reduces symptoms in idiopathic gastroparesis10 In our open label study patients had a 38 reduction in gastroparesis symptoms when interviewed 4 weeks after injection Seventy percent of patients had improved gastric emptying No immediate or short term within 6 months untoward events occurred in our study The beneficial effect of botulinum toxin injection was suggested to be through decreasing pyloric resistance however manometric analysis of this region was not performed Our results are similar to those seen in other studies that have demonstrated accelerated gastric emptying in response to pyloric botulinum toxin injection11-13 These studies have included groups of patients with both idiopathic and diabetic gastroparesis Unfortunately in all studies the patient groups have been very small and the study design has been open label that might bias results in favor of a positive response In addition follow-up has been for only 6 months
Despite limited data many gastroenterologists are now using botulinum toxin injection for the treatment of gastroparesis outside the context of clinical research studies We are concerned that this practice may be increasing nationwide without definitive proof of efficacy A randomized placebo-controlled trial is necessary to establish the usefulness of pyloric botulinum toxin injection for gastroparesis Botulinum toxin therapy is expensive and may not be efficacious In addition if efficacious the mechanism by which botulinum toxin improves gastric emptying needs to be studied This research protocol will answer several questions concerning this potentially useful therapy for gastroparesis
Botulinum toxin Botox Allergan is an inhibitor of cholinergic neuromuscular transmission and has been used to treat spastic disorders of both striated and smooth muscles by local injection into affected muscles9 Previous published work from our institution demonstrated that injection of botulinum toxin into the pylorus improved gastric emptying and reduces symptoms in idiopathic gastroparesis10 In our open label study patients had a 38 reduction in gastroparesis symptoms when interviewed 4 weeks after injection Seventy percent of patients had improved gastric emptying No immediate or short term within 6 months untoward events occurred in our study The beneficial effect of botulinum toxin injection was suggested to be through decreasing pyloric resistance however manometric analysis of this region was not performed Our results are similar to those seen in other studies that have demonstrated accelerated gastric emptying in response to pyloric botulinum toxin injection11-13 These studies have included groups of patients with both idiopathic and diabetic gastroparesis Unfortunately in all studies the patient groups have been very small and the study design has been open label that might bias results in favor of a positive response In addition follow-up has been for only 6 months
Despite limited data many gastroenterologists are now using botulinum toxin injection for the treatment of gastroparesis outside the context of clinical research studies We are concerned that this practice may be increasing nationwide without definitive proof of efficacy A randomized placebo-controlled trial is necessary to establish the usefulness of pyloric botulinum toxin injection for gastroparesis Botulinum toxin therapy is expensive and may not be efficacious In addition if efficacious the mechanism by which botulinum toxin improves gastric emptying needs to be studied This research protocol will answer several questions concerning this potentially useful therapy for gastroparesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None