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NCT00590538 · ClinicalTrials.gov registry record · Phase 1
Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis)
A Phase 1 study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00590538 is a Phase 1 study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 9 participants.
The verdict
NCT00590538, a Phase 1 study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
Interventions
- DRUG Placebo
- DRUG Sodium 4-Phenylbutyrate
- DRUG Genistein (Unconjugated Isoflavones 100)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2003-02 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590538
The ClinicalTrials.gov registry entry for NCT00590538 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00590538 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00590538 about?
NCT00590538 is a clinical study titled "Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis)". The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt...
What is the current status of trial NCT00590538?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2003-02. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00590538?
The interventions under investigation include: Placebo (DRUG), Sodium 4-Phenylbutyrate (DRUG), Genistein (Unconjugated Isoflavones 100) (DRUG).
Who is sponsoring clinical trial NCT00590538?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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