Pediatric Plaque PsoriasisPhase 3NCT00141921
Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis
A Phase 3 study testing Etanercept in people with Pediatric Plaque Psoriasis, run by Amgen.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Plaque Psoriasis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2005to 16 Aug 2017
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrollment on previous Amgen study 20030211 (NCT00078819)
Who cannot join
- Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept
About this study
Official title: An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
Read the detailed description
This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).
- Conditions
- Pediatric Plaque Psoriasis
- Being tested
- Etanercept
- Keywords
- Immunex, Amgen, Pediatric,, plaque psoriasis, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel®
Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
A serious adverse events is any AE that
- is fatal
- is life threatening
- requires in-patient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- is a congenital anomaly/birth defect
- other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity).
An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
Measured: 264 Weeks
Secondary outcomes (18)
Number of Participants With Injection Site Reactions
An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
Measured: 264 weeks
Exposure-adjusted Adverse Event Rates
The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period.
Exposure-adjusted event rate per 100 patient years = total number of events / patient years * 100.
Multiple occurrences of the same event for a participant were counted as multiple events.
Measured: 264 weeks
Number of Participants With Clinically Significant Changes in Vital Signs
Measured: 264 weeks
Number of Participants With Grade 3 and 4 Laboratory Toxicities
The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.
Measured: 264 weeks
Number of Participants Who Developed Anti-etanercept Antibodies
Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay.
Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline.
Measured: 264 weeks
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Measured: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percentage of Participants With a PASI 75 Response
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Measured: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percentage of Participants With a PASI 90 Response
A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Measured: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percent Improvement From Study 20030211 Baseline in PASI Score
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Measured: Weeks 12, 48, 96, 144, 192, 240 and 264
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but < 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Improvement From Study 20030211 Baseline in Joint Pain
Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10).
Improvement from baseline = (Baseline Value - Post-baseline Value).
Measured: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study start11 Aug 2005
- Primary completion19 Dec 2011
- Study completion16 Aug 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141921
- Sponsor's protocol ID
- 20050111
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2005
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Paller AS, Siegfried EC, Eichenfield LF, Pariser D, Langley RG, Creamer K, Kricorian G. Long-term etanercept in pediatric patients with plaque psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):762-8. doi: 10.1016/j.jaad.2010.04.004. Epub 2010 Jun 3.
PubMed 20605256Paller AS, Siegfried EC, Pariser DM, Rice KC, Trivedi M, Iles J, Collier DH, Kricorian G, Langley RG. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016 Feb;74(2):280-7.e1-3. doi: 10.1016/j.jaad.2015.09.056.
PubMed 26775775
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00141921
- Acronym / sponsor ID
- 20050111
- Conditions
- Pediatric Plaque Psoriasis
- Keywords
- Immunex, Amgen, Pediatric,, plaque psoriasis, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2005 (actual)
- Primary completion
- 19 Dec 2011 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Posted 10 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
Detailed description
This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: EtanerceptParticipants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Enrollment on previous Amgen study 20030211 (NCT00078819)
Key exclusion criteria (1 listed)
- Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept
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 |
|---|---|---|
| EtanerceptAlso: Enbrel®Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection | Drug | Etanercept |
Primary outcome
Number of Participants With Adverse Events
Time frame: 264 Weeks
A serious adverse events is any AE that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity). An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
18 secondary outcomes
Number of Participants With Injection Site Reactions
Time frame: 264 weeks
Exposure-adjusted Adverse Event Rates
Time frame: 264 weeks
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: 264 weeks
Number of Participants With Grade 3 and 4 Laboratory Toxicities
Time frame: 264 weeks
Number of Participants Who Developed Anti-etanercept Antibodies
Time frame: 264 weeks
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
Time frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percentage of Participants With a PASI 75 Response
Time frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percentage of Participants With a PASI 90 Response
Time frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percent Improvement From Study 20030211 Baseline in PASI Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
Time frame: Weeks 12, 48, 96, 144, 192, 240 and 264
Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
Improvement From Study 20030211 Baseline in Joint Pain
Time frame: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20605256Paller AS, Siegfried EC, Eichenfield LF, Pariser D, Langley RG, Creamer K, Kricorian G. Long-term etanercept in pediatric patients with plaque psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):762-8. doi: 10.1016/j.jaad.2010.04.004. Epub 2010 Jun 3.
- Background: PubMed 26775775Paller AS, Siegfried EC, Pariser DM, Rice KC, Trivedi M, Iles J, Collier DH, Kricorian G, Langley RG. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016 Feb;74(2):280-7.e1-3. doi: 10.1016/j.jaad.2015.09.056.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etanercept in people with Pediatric Plaque Psoriasis, run by Amgen.
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 1 inclusion and 1 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 5 Oct 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Feb 2017). 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?
Number of Participants With Adverse Events (time frame: 264 Weeks). 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 NCT00141921, which also lists 2 linked publications.
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 5 Oct 2017.