GSK Recruiting For Dutasteride Clinical Trials

[Mestys]

Apologies if this has been posted before but it seems GlaxoSmithKline are currently recruiting people for phase 3 trials.

"Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia"

http://clinicaltrials.gov/ct2/show/NCT0 ... de&rank=14

 

[2020]

what the hell. We know it works, why make any more tests?

What was wrong with this study:
http://www.clinicaltrials.gov/show/NCT00441116

 

[Mestys]

At the bottom..

"In a Phase II double-blind, placebo-controlled clinical study (ARIA2004) conducted in the United States, dutasteride demonstrated significant increases in target area hair count, as compared with placebo, as early as 12 weeks. In a Phase III double- blind, placebo-controlled clinical study conducted in Korea, dutasteride 0.5 milligram (mg) demonstrated significant increases in target area hair count, as compared with placebo, at 24 weeks. This 6 month study is being conducted to provide additional evidence of the efficacy and safety of three doses of dutasteride (0.02, 0.1 and 0.5mg) in the treatment of androgenetic alopecia, and more specifically, to characterize the dose-response relationship in an ethnically-diverse population. Treatment arms will be equally balanced with approximately 180 per arm."

 

[Bryan]

At the bottom..

"In a Phase II double-blind, placebo-controlled clinical study (ARIA2004) conducted in the United States, dutasteride demonstrated significant increases in target area hair count, as compared with placebo, as early as 12 weeks. In a Phase III double- blind, placebo-controlled clinical study conducted in Korea, dutasteride 0.5 milligram (mg) demonstrated significant increases in target area hair count, as compared with placebo, at 24 weeks. This 6 month study is being conducted to provide additional evidence of the efficacy and safety of three doses of dutasteride (0.02, 0.1 and 0.5mg) in the treatment of androgenetic alopecia, and more specifically, to characterize the dose-response relationship in an ethnically-diverse population. Treatment arms will be equally balanced with approximately 180 per arm."

It's not a "Phase III" study if it's only six months long! That's no different from the older study that was done a few years ago (2002?) that first got people interested in dutasteride. A real "Phase III" study would be similar to the one that Merck did with finasteride; that one lasted for two full years, and involved thousands of people.

 

[Mestys]

If it's not Phase 3 then why have they called it Phase 3 on a government website?

 

[Bryan]

If it's not Phase 3 then why have they called it Phase 3 on a government website?

Must be a simple mistake somebody made in the past.

 

[Mestys]

Hardly seems like a mistake when the last clinical trial in the USA GSK did was Phase II in 2002.

Also 5AR inhibitors have been proven to work for hair loss thanks to Propecia. Maybe GSK don't need as many people in the trial for that reason.

 

[Bryan]

Hardly seems like a mistake when the last clinical trial in the USA GSK did was Phase II in 2002.

I don't understand your point at all. Please explain.

Also 5AR inhibitors have been proven to work for hair loss thanks to Propecia. Maybe GSK don't need as many people in the trial for that reason.

You think just because Merck was able to successfully complete a Phase III study a few years ago with finasteride, the government has now relaxed the standard definitions of these terms (Phase I, Phase II, Phase III, etc.), and no longer require them to be defined as precisely as they used to be?

I seriously doubt that. I really do.

 

[Mestys]

I see your point.

I found this from clinicaltrials.gov

"In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely."

There is no mention about the length a Phase III trial should be. It seems GSK estimate to enrol 900 people.

What I meant by that comment was that the last trial they did was Phase II, it makes sense the next is Phase III.

Either way, It's intriguing that GSK still have some interest in using Dutasteride to treat Androgenetic Alopecia.

 

[Bryan]

What I meant by that comment was that the last trial they did was Phase II, it makes sense the next is Phase III.

The new trial they did in Korea is virtually IDENTICAL to the one they did in 2002. They both had the same duration, and the same test-dosages. I think it was just a slip of someone's tongue to call the newer one a "Phase III" study.

Either way, It's intriguing that GSK still have some interest in using Dutasteride to treat Androgenetic Alopecia.

I agree, especially considering that they're not even going for FDA approval for the treatment of male pattern baldness. I think that's yet another reason not to pay too much attention to the specific kind of study that somebody decides to call it!