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NCT00372970 · ClinicalTrials.gov registry record · NA
Placebo Controlled Trial of Botulinum Toxin for Gastroparesis
A NA study, sponsored by Temple University.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT00372970: Completed NA study, sponsored by Temple University.
NCT00372970 is a NA study that has completed, run by Temple University. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00372970, a NA study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be \>=27. In a previous study internal consistency reliability
Interventions
- DRUG Placebo
- DRUG Botulinum toxin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2003-07 |
| Est. Completion | 2008-12 |
| Phase | NA |
What the finished NCT00372970 record still lists
NCT00372970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00372970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00372970 about?
NCT00372970 is a clinical study titled "Placebo Controlled Trial of Botulinum Toxin for Gastroparesis". 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...
What is the current status of trial NCT00372970?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2003-07. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00372970?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin A (DRUG).
Who is sponsoring clinical trial NCT00372970?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00372970's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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