OnychomycosisPhase 2NCT00730405

Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

A Phase 2 study testing Albaconazole 100mg, Albaconazole 200mg and Albaconazole 400mg in people with Onychomycosis, run by Stiefel, a GSK Company at 33 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Onychomycosis
What is being tested?: Albaconazole 100mg, Albaconazole 200mg and Albaconazole 400mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 582 participants
Where: 33 sitesin 3 countries
Study dates: 16 Jul 2008to 19 Feb 2010
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

Subject aged 18 to 75 years.
Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
Subject is able to complete the study, comply with study instructions, and take study product orally.
Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product.
Women of childbearing potential must have a negative pregnancy test at enrollment.
Subject has screening laboratory parameters and ECG within the normal ranges unless considered to be not clinically relevant by the principal investigator.

Who cannot join

Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):
Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product.
Subject is receiving any drugs that are known substrates of the 3A4 isozyme of cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant medications listed under prohibited medication section.
Subject has a history of known or suspected intolerance to albaconazole or the formulation excipients, or to azole antifungal drugs in general.
Subject has previously participated in a clinical study with albaconazole.

Show all 15Show fewer

Subject is not prepared to give up use of any nail cosmetic products for the duration of the study.
Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
Subject has any known liver disease or a history of liver toxicity with other drugs.
Subject is currently suffering from any disease or condition, that could include abnormal laboratory tests, and/or who are currently using medication which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal toenail.
Subject has a history of any condition that could possibly affect absorption of drug (eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular disease or peripheral circulatory impairment, or has had any major illness within 30 days prior to the screening examination.
Subject has a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
Female subjects who are pregnant, trying to become pregnant, or lactating.
Employees of Investigator/clinical research organization (CRO) or Stiefel Laboratories, Inc., or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.

Trial locations and contacts

33 sites in 3 countries.

Country

City, postcode or hospital

33 sites in 3 countries

United States29 sites

DermResearch, Inc.
Austin, Texas, 78759
Impact Clinical Trials
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Northern California Research
Carmichael, California, 95608
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
J & S Studies, Inc.
College Station, Texas, 77845
Thomas J. Stephens & Associates, Inc. Colorado Research Center
Colorado Springs, Colorado, 80915
Research Across America
Dallas, Texas, 75234
Henry Ford Medical Center
Detroit, Michigan, 48202
Welborn Clinic
Evansville, Indiana, 47713
Center for Dermatology Clinical Research
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Center for Clinical Studies
Houston, Texas, 77058
The Skin Wellness Center
Knoxville, Tennessee, 37922
Education and Research Foundation
Lynchburg, Virginia, 24501
International Dermatology Research Inc
Miami, Florida, 33144
Greater Miami Skin & Laser Center
Miami Beach, Florida, 33140
Tennessee Clinical Research
Nashville, Tennessee, 37215
NYU Medical Center
New York, New York, 10016
MedaPhase, Inc
Newnan, Georgia, 30263
Miami Dermatology Research Institute LLC
North Miami Beach, Florida, 33169
Skin Specialists, Inc
Omaha, Nebraska, 68144
Oregon Dermatology & Research Centre
Portland, Oregon, 97210
Oregon Medical
Portland, Oregon, 97223
DermatologyResearch Center
Salt Lake City, Utah, 84124
Therapeutics Clinical Research
San Diego, California, 92123
UCSF Dermatology Research
San Francisco, California, 94115
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Genova Clinical Research
Tucson, Arizona, 85791

Other trials in United States

Canada3 sites

Ultranova Skincare
Barrie, Ontario, L4M 6L2
North Bay Dermatology Centre Inc.
North Bay, Ontario, P1B 3Z7
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4

Other trials in Canada

Iceland1 site

Dermatology Centre, University of Iceland
Hudlaeknaslodin, Kopavogur, 201

Other trials in Iceland

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the Efficacy and Safety of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.

Read the detailed description

A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus

Conditions: Onychomycosis
Being tested: Albaconazole 100mg, Albaconazole 200mg, Albaconazole 400mg, Placebo 400 mg
Keywords: Distal, Subungual onychomycosis, onychomycosis, nail fungus, Toenail fungus
Medical subject headings: Onychomycosis

What participants receive

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

Albaconazole 100mgDrug
Albaconazole for 36 weeks
Albaconazole 200mgDrug
Albaconazole for 36 weeks
Albaconazole 400mgDrug
Albaconazole for 36 weeks
Albaconazole 400mgDrug
Albaconazole for 24 weeks, Placebo for 12 weeks
Placebo 400 mgDrug
Placebo for 36 weeks

Study groups in NCT00730405
Study group	Role	What they receive
Albaconazole 100mg	Active comparator	Albaconazole for 36 weeks Receives: Drug: Albaconazole 100mg
Albaconazole 200mg	Active comparator	Albaconazole for 36 weeks Receives: Drug: Albaconazole 200mg
Albaconazole 400mg	Active comparator	Albaconazole for 36 weeks Receives: Drug: Albaconazole 400mg
Albaconazole 400mg 24 weeks, Placebo 12 weeks	Active comparator	Albaconazole for 24 weeks, Placebo for 12 weeks Receives: Drug: Albaconazole 400mg; Drug: Placebo 400 mg
Placebo 400 mg	Placebo comparator	Placebo for 36 weeks Receives: Drug: Placebo 400 mg

What is being measured

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

The Percentage of Participants Who Achieve Effective Treatment at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Measured: Week 52

Secondary outcomes (5)

The Percentage of Participants Who Achieve Clinical Cure at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Measured: Week 52
The Percentage of Participants Who Achieve Mycological Cure at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52.
Measured: Week 52
The Percentage of Participants Who Achieve Complete Cure at Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Measured: Week 52
Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52
Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean.
Measured: Baseline (Week 0/Day 1 or before) and up to Week 52
The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52
A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator's assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail.
Measured: Week 52

Timeline

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

16 Jul 200819 Feb 2010

First posted8 Aug 2008 (estimated)
Study start16 Jul 2008
Primary completion19 Feb 2010
Study completion19 Feb 2010

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.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 582 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730405
Sponsor's protocol ID: 114554
Status last verified: Jan 2018
First submitted: 4 Aug 2008
Last updated: 12 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sigurgeirsson B, van Rossem K, Malahias S, Raterink K. A phase II, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of oral albaconazole in patients with distal subungual onychomycosis. J Am Acad Dermatol. 2013 Sep;69(3):416-25. doi: 10.1016/j.jaad.2013.03.021. Epub 2013 May 22.
PubMed 23706639

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?

See locations

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Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
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All Onychomycosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the Efficacy and Safety of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
ClinicalTrials.gov ID: NCT00730405
Acronym / sponsor ID: 114554
Conditions: Onychomycosis
Keywords: Distal, Subungual onychomycosis, onychomycosis, nail fungus, Toenail fungus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 582 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 16 Jul 2008 (actual)
Primary completion: 19 Feb 2010 (actual)
Study completion: 19 Feb 2010 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 7 Feb 2018

Clinical summary

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

Phase 2 study to examine how the study drug works and its side effects in subjects with toenail fungus.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Albaconazole 100mg	Active comparator	Drug: Albaconazole 100mgAlbaconazole for 36 weeks
Albaconazole 200mg	Active comparator	Drug: Albaconazole 200mgAlbaconazole for 36 weeks
Albaconazole 400mg	Active comparator	Drug: Albaconazole 400mgAlbaconazole for 36 weeks
Albaconazole 400mg 24 weeks, Placebo 12 weeks	Active comparator	Drug: Albaconazole 400mg, Drug: Placebo 400 mgAlbaconazole for 24 weeks, Placebo for 12 weeks
Placebo 400 mg	Placebo comparator	Drug: Placebo 400 mgPlacebo for 36 weeks

Who may qualify

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

Key inclusion criteria (7 listed)

Subject aged 18 to 75 years.
Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
Subject is able to complete the study, comply with study instructions, and take study product orally.
Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product.

Key exclusion criteria (15 listed)

Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):
Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product.
Subject is receiving any drugs that are known substrates of the 3A4 isozyme of cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant medications listed under prohibited medication section.
Subject has a history of known or suspected intolerance to albaconazole or the formulation excipients, or to azole antifungal drugs in general.

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
Albaconazole 100mgAlbaconazole for 36 weeks	Drug	Albaconazole 100mg
Albaconazole 200mgAlbaconazole for 36 weeks	Drug	Albaconazole 200mg
Albaconazole 400mgAlbaconazole for 36 weeks	Drug	Albaconazole 400mg
Albaconazole 400mgAlbaconazole for 24 weeks, Placebo for 12 weeks	Drug	Albaconazole 400mg 24 weeks, Placebo 12 weeks
Placebo 400 mgPlacebo for 36 weeks	Drug	Albaconazole 400mg 24 weeks, Placebo 12 weeks, Placebo 400 mg

Primary outcome

The Percentage of Participants Who Achieve Effective Treatment at Week 52
Time frame: Week 52
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.

5 secondary outcomes

The Percentage of Participants Who Achieve Clinical Cure at Week 52
Time frame: Week 52
The Percentage of Participants Who Achieve Mycological Cure at Week 52
Time frame: Week 52
The Percentage of Participants Who Achieve Complete Cure at Week 52
Time frame: Week 52
Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52
Time frame: Baseline (Week 0/Day 1 or before) and up to Week 52
The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 7 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Albaconazole 400 mg (36 Weeks) Oral Weekly	116	97
Albaconazole 400 mg (24 Weeks) Oral Weekly	117	96
Albaconazole 200 mg (36 Weeks) Oral Weekly	117	96
Albaconazole 100 mg (36 Weeks) Oral Weekly	117	98
Placebo	115	95

Primary outcome: The Percentage of Participants Who Achieve Effective Treatment at Week 52

Time frame: Week 52. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Albaconazole 400 mg (36 Weeks) Oral Weekly n = 116	Albaconazole 400 mg (24 Weeks) Oral Weekly n = 117	Albaconazole 200 mg (36 Weeks) Oral Weekly n = 117	Albaconazole 100 mg (36 Weeks) Oral Weekly n = 117	Placebo n = 115
Value	54 (45.2 to 63.4)	38 (28.8 to 46.4)	29 (20.8 to 37.3)	21 (13.2 to 27.8)	1 (0.0 to 2.6)

Albaconazole 400 mg (36 Weeks) Oral Weekly vs Placebo: p <0.001, Cochran-Mantel-Haenszel
Albaconazole 400 mg (24 Weeks) Oral Weekly vs Placebo: p <0.001, Cochran-Mantel-Haenszel
Albaconazole 200 mg (36 Weeks) Oral Weekly vs Placebo: p <0.001, Cochran-Mantel-Haenszel

Population analysed: The intent-to-treat (ITT) analysis set consists of all randomized participants who receive study product. All participants were available at the time of assessment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albaconazole 400 mg (36 Weeks) Oral Weekly	4 of 116 (3.4%)	0 of 0	0 of 116
Albaconazole 400 mg (24 Weeks) Oral Weekly	7 of 117 (6%)	0 of 0	1 of 117
Albaconazole 200 mg (36 Weeks) Oral Weekly	3 of 117 (2.6%)	0 of 0	0 of 117
Albaconazole 100 mg (36 Weeks) Oral Weekly	6 of 117 (5.1%)	0 of 0	1 of 117
Placebo	2 of 115 (1.7%)	0 of 0	0 of 115

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23706639Sigurgeirsson B, van Rossem K, Malahias S, Raterink K. A phase II, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of oral albaconazole in patients with distal subungual onychomycosis. J Am Acad Dermatol. 2013 Sep;69(3):416-25. doi: 10.1016/j.jaad.2013.03.021. Epub 2013 May 22.
Results for study 114554 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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.

GSK Clinical Trials study director

GlaxoSmithKline

33 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Albaconazole 100mg, Albaconazole 200mg and Albaconazole 400mg in people with Onychomycosis, run by Stiefel, a GSK Company at 33 sites in 3 countries.

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 7 inclusion and 15 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

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 7 Feb 2018). 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?

The Percentage of Participants Who Achieve Effective Treatment at Week 52 (time frame: Week 52). 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 NCT00730405, 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 12 Mar 2018.