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oral anti-acid treatment for Gastrocutaneous Fistula (GCF Trial)
GCF Trial Summary
This trial looks at whether a non-surgical bundle can help prevent or treat gastrocutaneous fistulas, which are a common complication of gastrostomy tubes.
- Gastrocutaneous Fistula
- Gastrostomy Complications
GCF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.GCF Trial Design
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Who is running the clinical trial?
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- You have a recurring opening between your stomach and skin.You have had an allergic reaction to the study products.You are able to have your feeding tube removed.
- Group 1: Intervention
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are included in the current research program?
"Affirmative. Clinicaltrials.gov exhibits that this research is actively enlisting participants, since its initial posting on April 1st 2019 and latest update on January 6th 2022. 100 individuals will be welcomed across a single site for the trial's duration."
What precedent exists for the effectiveness of oral anti-acid treatment, based on prior clinical trials?
"Presently, 3 studies are underway exploring oral anti-acid treatment. One of these experiments is currently in the third phase. Most research into this type of treatment is taking place in Vancouver, BC; though there are 3 other clinical sites conducting trials as well."
Are there any adverse effects associated with oral anti-acid therapy?
"This oral anti-acid treatment has been given the highest safety rating of 3, due to its acceptance as an approved drug following a successful Phase 4 trial."
Are new participants being accepted for this experiment at present?
"Affirmative. Clinicaltrials.gov corroborates that this study, which was initially listed on April 1st 2019, is actively recruiting volunteers. This clinical trial requires 100 candidates to be sourced from a single medical centre."
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