Dutasteride Phase 4 Study in South Korea
I’m 25 years old from Israel and I’m a big fan of your website and very impressed by the elaborate answers you give. As part of my research of treating my own hair loss, I read a lot about dutasteride (Avodart) and ran into this clinical trial.
It looks like GSK is doing the last phase before taking it out to the market as a hair loss product. What is your opinion about this study:
Thank you for bringing this to our attention. I really don’t have anything to add, as this Phase IV study just started in April and isn’t scheduled to end until 2013. There’s not much info available beyond what is listed on that summary page.
The US ClinicalTrials.gov glossary describes the four phases of clinical trials: “Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.”
The glossary further defines Phase IV as: “Post-marketing studies to delineate additional information including the drug’s risks, benefits, and optimal use.”
So while Phase IV trials are generally done after the drug is already approved by the FDA (at least in the US), perhaps things are different with the phases outlined by the Korea FDA. Searching the Korea FDA site isn’t proving too helpful. I do know that Avodart (dutasteride) isn’t approved for treating hair loss yet in the US, though. Any readers out there with some knowledge about the various clinical trial phases and how they might different by country, please feel free to set me straight in the comments section.
In Korea, Phase 4 trials (similar to other countries) are after approval of a drug. The study is thus described in the announcement as a “post-marketing surveillance” trial and is both for safety and open-label (no control group), also common features of postmarketing studies. As I am not aware of Avodart approval for MPB in Korea yet, the description of the study (and the mention that it is now recruiting patients) as a Phase 4 postmarketing trial is confusing to me. However, there is also an inconsistency in the description: the study is described as “recruiting” in a top row, but in a bottom row it is mentioned that “No locations currently recruiting for this study.” So, easiest way to clarify for those interested is to call the GSK number provided for prospective patients or investigators.
using doctors who currently prescibe this medication to recruit patients for the study****
sorry my comments are kind of jittery but if you attempt to follow along with it i think you will find my point is valid.
so in summary, phase 4 trials are appropriate because it is only expanding use of an already approved drug. There is no contradiction whatsoever here.
In addition:
THIS HERE:
•Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with dutasteride following the locally approved Prescribing Information
EXPLAINS
No locations currently recruiting for this study.
THAT THERE ^
their*
lolz
Where are my other comments? It says 11 comments. But I count 6. I made more comments explaining this.
Dr. Lyn,
Let me shed light on this issue to alleviate your confusion.
In regards to FDA clinical trials on drugs already approved for one use, there need only be phase 4 trials to extend its use in treating other ailments. As you know, Avodart is already approved for BPH, so Phase 4 Trials are the expected and appropriate step to extend its approval to MPB.
Dr. Lyn,
There is no inconsistency. They are not recruiting because it is an observational study on patients already being prescribed the medicine for an already approved use. Doctors are simply observing those already prescribed the medicine. That is why they do not need to recruit anyone.
https://clinicaltrials.gov/ct2/show/NCT01004809
how convenient that study completion so closely coincides with Propecia’s patent expiration.
Today is August 1, 2013. Study completion set for July, 2013.
Any updates?
Glaxo has published a results summary of this trial here:
https://www.gsk-clinicalstudyregister.com/study/113797#rs