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

NCT00491764 | Completed Phase 2 Results

• 1 other identifier: P05082
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48

• Treatment Success of Onychomycosis at Week 48

  Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48

Study Arms (6)

Posaconazole 100 mg QD for 24 weeks.

EXPERIMENTAL

Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.

Drug: SCH 56592

Posaconazole 200 mg QD for 24 weeks.

EXPERIMENTAL

Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.

Drug: SCH 56592

Posaconazole 400 mg QD for 24 weeks.

EXPERIMENTAL

Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.

Drug: SCH 56592

Posaconazole 400 mg QD for 12 weeks.

EXPERIMENTAL

Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.

Drug: SCH 56592

Terbinafine

ACTIVE COMPARATOR

Terbinafine 250 mg QD for 12 weeks.

Drug: Terbinafine

Placebo

PLACEBO COMPARATOR

Placebo for 24 weeks.

Drug: Placebo

Interventions

SCH 56592 DRUG

Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.

Also known as: Posaconazole, Noxafil

Posaconazole 100 mg QD for 24 weeks.

Terbinafine DRUG

Terbinafine 250 mg QD for 12 weeks.

Terbinafine

Placebo DRUG

Placebo for 24 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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,
• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21967490 DERIVED

MeSH Terms

Conditions

Onychomycosis

Interventions

posaconazole; Terbinafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 7, 2017
• Results First Posted: January 28, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share