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View Clinical Trial (Medical Research Study)
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Placebo Controlled Trial of Botulinum Toxin for Gastroparesis - NCT00372970-19140 (Clinical Trial 148483)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy148483.aspx
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| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19140 |
| Conditions: |
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Gastroparesis |
| Purpose: |
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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.
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| Study summary: |
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Patients with gastroparesis, or delayed gastric emptying, present with early satiety,
postprandial bloating, nausea, vomiting, and abdominal pain or discomfort.1 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
gastroparesis.2-4 Current treatment for gastroparesis employs prokinetic agents that
increase antral contractility and accelerate gastric emptying.5 Unfortunately, prokinetic
agents have limited efficacy and trials of these agents have suffered from significant
methodological flaws.6 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, A.H. Robins) have limited the usefulness of these agents.7
Domperidone may be effective for treating symptoms of gastroparesis, however it is
unavailable in the U.S.8
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 muscles.9 Previous published work from our institution demonstrated
that injection of botulinum toxin into the pylorus improved gastric emptying and reduces
symptoms in idiopathic gastroparesis.10 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 injection.11-13 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. |
| Criteria: |
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Inclusion Criteria:
- Documented gastroparesis by radiologic study
- No ulcer disease
- Only surgery history must be either appendectomy or cholecystectomy
- No prior treatment with Botox
Exclusion Criteria:
- Prior botox injection |
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| Study is available at: |
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Temple University Hospital
Philadelphia, PA 19140
United States
Primary Contact:
Frank Friedenberg, MD
Email: frank.friedenberg@temple.edu
Phone: 215-707-3431 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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