OnychomycosisPhase 2NCT00491764

A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)

A Phase 2 study testing SCH 56592 and Terbinafine in people with Onychomycosis, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral administration of four dosing regimens of posaconazole relative to placebo and terbinafine, in the treatment of toenail onychomycosis. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Onychomycosis
What is being tested?: SCH 56592 and Terbinafine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 218 participants
Where: No sites listed yet
Study dates: Jun 2007to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject must meet ALL the criteria listed below for entry:
Subject must be between 18 and 75 years of age inclusive, of either sex, and of any race;
Subject must have distal subungual infection that affects approximately 25% to 75% of at least one great toenail, both clinically and mycologically diagnosed;
Subject must have at least 2 mm of the proximal end of the target toenail free of infection;
Subject must have a target toenail that is assessed as capable of growing approximately 1 mm/month, (eg, the subject needs to report cutting his or her toenails at least once per month);
Subject must have liver function tests within 1.5 x the upper limit of normal (bilirubin and transaminases);

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Subject must have normal serum creatinine levels;
Subject must be able to take study medication orally;
Subject must have no history of current narcotic or alcohol addiction;
Subject must be willing to give written informed consent and able to adhere to dose, procedures, and visit schedules;
Woman of childbearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 30 days after stopping the medication. Methods include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive (plus an additional reliable barrier method), and surgical sterilization (eg, hysterectomy or tubal ligation).
Woman of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
Woman of childbearing potential must have a negative serum pregnancy test within 72 hours prior to start of study drug.

Who cannot join

The subject will be excluded from entry if ANY of the criteria listed below are met:
Subject with one or more of the following conditions on the target toenail:
proximal subungual onychomycosis,
white superficial onychomycosis,
dermatophytoma or "yellow spike/streak",
exclusively lateral disease,

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inability to become normal in the opinion of the investigator.
Subject with psoriasis, severe moccasin-type tinea pedis requiring treatment, symptomatic interdigital tinea pedis, lichen planus, or other abnormalities that could result in a clinically abnormal nail;
Subject with peripheral vascular disease or peripheral circulatory impairment;
Subject with history of uncontrolled diabetes mellitus;
Subject with known chronic or active liver disease;
Subject with any known immunodeficiency;
Subject with a family history of long QT syndrome;
Subject with an electrocardiogram with QTc interval prolongation greater than 450 msec for males and 470 msec for females;
Subject with potassium or magnesium lower than the lower limit of normal;
Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study;
Subject who has received systemic antifungal therapy within 3 months or topical antifungal therapy applied to the foot or toenails within 1 month of study entry;
Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of Randomization, and/or oral corticosteroids for >1 month within the 6 months of Randomization (exception: inhaled steroids);
Subject using medications known to interact with azoles such as terfenadine, pimozide, quinidine, halofantrine, astemizole, alfentanil, cisapride, HMG-Co A (3-hydroxy-3-methylglutaryl coenzyme A) reductase inhibitors that are metabolized by CYP3A4, and ebastine, within 7 days prior to Randomization; and pravastatin within 14 days prior to Randomization;
Subject using medications known to lower the serum concentration/efficacy of azoles including rifampin, rifabutin, cimetidine, carbamazepine, phenytoin, barbiturates, and isoniazid, 3 doses or more within 7 days prior to Randomization;
Subject with a known sensitivity to azoles, POS and/or its excipients, terbinafine and/or its excipients;
Subject who has been previously enrolled in this study or any other POS investigational trial;
Subject known to have received treatment with investigational drugs within 30 days prior to enrollment into this study;
Woman who is breastfeeding, pregnant, or intends to become pregnant;
Subject who is part of the staff personnel directly involved with this study;
Subject who is a family member of the investigational study staff.

About this study

Official title: An Investigator-Blinded Study Evaluating the Efficacy and Safety of Four Posaconazole Treatment Regimens With Placebo and Terbinafine in the Treatment of Onychomycosis of the Toenail

Conditions: Onychomycosis
Being tested: SCH 56592, Terbinafine, Placebo
Medical subject headings: Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCH 56592Drug
Also called Posaconazole, Noxafil
Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.
SCH 56592Drug
Also called Posaconazole, Noxafil
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
SCH 56592Drug
Also called Posaconazole, Noxafil
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
SCH 56592Drug
Also called Posaconazole, Noxafil
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
TerbinafineDrug
Terbinafine 250 mg QD for 12 weeks.
PlaceboDrug
Placebo for 24 weeks.

Study groups in NCT00491764
Study group	Role	What they receive
Posaconazole 100 mg QD for 24 weeks.	Experimental	Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. Receives: Drug: SCH 56592
Posaconazole 200 mg QD for 24 weeks.	Experimental	Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. Receives: Drug: SCH 56592
Posaconazole 400 mg QD for 24 weeks.	Experimental	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. Receives: Drug: SCH 56592
Posaconazole 400 mg QD for 12 weeks.	Experimental	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. Receives: Drug: SCH 56592
Terbinafine	Active comparator	Terbinafine 250 mg QD for 12 weeks. Receives: Drug: Terbinafine
Placebo	Placebo comparator	Placebo for 24 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Cure of Onychomycosis at Week 48.
Complete cure is defined as negative mycology (negative culture and KOH [potassium hydroxide]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).
Measured: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48

Secondary outcomes (2)

Effective Treatment of Onychomycosis at Week 48.
Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or >5 mm growth of unaffected nail
Measured: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48
Treatment Success of Onychomycosis at Week 48
Treatment success was defined as negative mycology (negative culture and negative KOH) and =<10% nail involvement.
Measured: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Dec 2008

First posted26 Jun 2007 (estimated)
Study startJun 2007
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OnychomycosisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00491764
Sponsor's protocol ID: P05082
Status last verified: Mar 2017
First submitted: 25 Jun 2007
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Elewski B, Pollak R, Ashton S, Rich P, Schlessinger J, Tavakkol A. A randomized, placebo- and active-controlled, parallel-group, multicentre, investigator-blinded study of four treatment regimens of posaconazole in adults with toenail onychomycosis. Br J Dermatol. 2012 Feb;166(2):389-98. doi: 10.1111/j.1365-2133.2011.10660.x. Epub 2011 Dec 6.
PubMed 21967490

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail

All Onychomycosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigator-Blinded Study Evaluating the Efficacy and Safety of Four Posaconazole Treatment Regimens With Placebo and Terbinafine in the Treatment of Onychomycosis of the Toenail
ClinicalTrials.gov ID: NCT00491764
Acronym / sponsor ID: P05082
Conditions: Onychomycosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 26 Jun 2007 (estimated)
Results: Posted 28 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 6

Arm	Type	Receives
Posaconazole 100 mg QD for 24 weeks.	Experimental	Drug: SCH 56592Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.
Posaconazole 200 mg QD for 24 weeks.	Experimental	Drug: SCH 56592Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
Posaconazole 400 mg QD for 24 weeks.	Experimental	Drug: SCH 56592Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
Posaconazole 400 mg QD for 12 weeks.	Experimental	Drug: SCH 56592Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
Terbinafine	Active comparator	Drug: TerbinafineTerbinafine 250 mg QD for 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo for 24 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

The subject must meet ALL the criteria listed below for entry:
Woman of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
Woman of childbearing potential must have a negative serum pregnancy test within 72 hours prior to start of study drug.

Key exclusion criteria (26 listed)

The subject will be excluded from entry if ANY of the criteria listed below are met:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCH 56592Also: Posaconazole, NoxafilPosaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.	Drug	Posaconazole 100 mg QD for 24 weeks.
SCH 56592Also: Posaconazole, NoxafilPosaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.	Drug	Posaconazole 200 mg QD for 24 weeks.
SCH 56592Also: Posaconazole, NoxafilPosaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.	Drug	Posaconazole 400 mg QD for 24 weeks.
SCH 56592Also: Posaconazole, NoxafilPosaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.	Drug	Posaconazole 400 mg QD for 12 weeks.
TerbinafineTerbinafine 250 mg QD for 12 weeks.	Drug	Terbinafine
PlaceboPlacebo for 24 weeks.	Drug	Placebo

Primary outcome

Complete Cure of Onychomycosis at Week 48.
Time frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48
Complete cure is defined as negative mycology (negative culture and KOH [potassium hydroxide]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).

2 secondary outcomes

Effective Treatment of Onychomycosis at Week 48.
Time frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48
Treatment Success of Onychomycosis at Week 48
Time frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48

Results and safety

Results posted to the registry on 28 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Posaconazole 100 mg QD for 24 Weeks	37	32
Posaconazole 200 mg QD for 24 Weeks.	37	30
Posaconazole 400 mg QD for 24 Weeks.	36	28
Posaconazole 400 mg QD for 12 Weeks.	36	28
Terbinafine 250 mg QD for 12 Weeks.	36	33
Placebo for 24 Weeks	36	27

Primary outcome: Complete Cure of Onychomycosis at Week 48.

Time frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48. Number. Unit: Participants

Measure	Posaconazole 100 mg QD for 24 Weeks n = 35	Posaconazole 200 mg QD for 24 Weeks. n = 37	Posaconazole 400 mg QD for 24 Weeks. n = 33	Posaconazole 400 mg QD for 12 Weeks. n = 35	Terbinafine 250 mg QD for 12 Weeks. n = 35	Placebo for 24 Weeks n = 32
Value	8	20	15	7	13	0

Posaconazole 100 mg QD for 24 Weeks vs Placebo for 24 Weeks: Mean Difference (Net): 22.9 (95% CI 8.9 to 36.8), p = 0.005, Fisher Exact
Posaconazole 200 mg QD for 24 Weeks. vs Placebo for 24 Weeks: Mean Difference (Net): 54.1 (95% CI 38.0 to 70.1), p <0.001, Fisher Exact
Posaconazole 400 mg QD for 24 Weeks. vs Placebo for 24 Weeks: Mean Difference (Net): 45.5 (95% CI 28.5 to 62.4), p <0.001, Fisher Exact

Population analysed: This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Posaconazole 100 mg QD for 24 Weeks	1 of 36 (2.8%)	26 of 36 (72.2%)	Not reported
Posaconazole 200 mg QD for 24 Weeks	1 of 37 (2.7%)	21 of 37 (56.8%)	Not reported
Posaconazole 400 mg QD for 24 Weeks	1 of 36 (2.8%)	20 of 36 (55.6%)	Not reported
Posaconazole 400 mg QD for 12 Weeks	1 of 36 (2.8%)	18 of 36 (50%)	Not reported
Terbinafine 250 mg QD for 12 Weeks	0 of 36 (0%)	20 of 36 (55.6%)	Not reported
Placebo for 24 Weeks	3 of 35 (8.6%)	21 of 35 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21967490Elewski B, Pollak R, Ashton S, Rich P, Schlessinger J, Tavakkol A. A randomized, placebo- and active-controlled, parallel-group, multicentre, investigator-blinded study of four treatment regimens of posaconazole in adults with toenail onychomycosis. Br J Dermatol. 2012 Feb;166(2):389-98. doi: 10.1111/j.1365-2133.2011.10660.x. Epub 2011 Dec 6.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Onychomycosis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCH 56592 and Terbinafine in people with Onychomycosis, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Cure of Onychomycosis at Week 48. (time frame: Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00491764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.