HIV PreventionPhase 1NCT01575418
An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations
A Phase 1 study testing Rectal formulation (RF) of tenofovir 1% gel, Vaginal formulation (VF) of tenofovir 1% gel and Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel in people with HIV Prevention, run by Ian McGowan at 1 site in United States.
Trial summary
This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Rectal formulation (RF) of tenofovir 1% gel, Vaginal formulation (VF) of tenofovir 1% gel and Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ Age of 18 at screening
- Willing and able to communicate in English
- Willing and able to provide written informed consent to take part in the study
- Willing and able to provide adequate locator information
- Understands and agrees to local STI reporting requirements
- Biologically male
- HIV-1 uninfected at screening according to the standard DAIDS algorithm 8. Willingness to provide semen sample on multiple occasions
- 9. Per participant report at screening, a history of consensual RAI at least once within the six months prior to screening 10. Willingness to perform simulated RAI with CDS device 11. Willing to abstain from RAI or any practices which include rectal insertion of any product including those used during sexual intercourse (sex toys) for 48 hours before and after inpatient dosing and willing to refrain from ejaculation for a period of 48 hours prior to each semen collection 12. Must agree to use condoms for the duration of the study 13. Must be in general good health 14. Must agree not to participate in other drug trials 15. Availability to return for all study visits, barring unforeseen circumstances
Who cannot join
- Significant colorectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic external hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation.)
- At screening: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. Note that HSV seropositivity with no active genital lesions is not an exclusion criterion, since treatment is not required. (Note: Allow one re-screening after documented treatment (30 days) in cases where urethral GC/CT identified at screening)
- At screening:
- Positive for hepatitis B surface antigen
- Calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140 - age in years) x (weight in kg) x (1 for male)/72 x (serum creatinine in mg/dL)
- Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site laboratory ULN
Show all 13Show fewer
- Known allergic reaction to methylparaben, propylparaben, sorbic acid, glycerin, glycerol, tenofovir, or other components of the test articles
- Known HIV-infected partners
- By participant report at enrollment, history of excessive daily alcohol use (as defined by the CDC as heavy drinking consisting of an average consumption of more than 2 drinks per day for men), frequent binge drinking or illicit drug use that includes any injection drugs, methamphetamines (crystal meth), heroin, or cocaine including crack cocaine, within the past 12 months
- By participant report, use of any rectally-administered medications, rectally administered products containing N-9 (including condoms), any investigational products, and/or systemic immunomodulatory medications within the 4 weeks prior to the first inpatient visit and throughout study participation
- History of recurrent urticaria
- Participants whose whole body (EDE) radiation exposure, per the investigator's records and/or participant report, exceeds 5000mrem/year
- Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, Division of Clinical Pharmacology, Drug Development Unit
Baltimore, Maryland, 21205
About this study
Official title: An Exploratory, Double-Blinded, Randomized, Pharmacokinetic and Safety Study of Three Rectally-Applied Tenofovir 1% Microbicide Gel Formulations
This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be enrolled.
Each participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose.
- Conditions
- HIV Prevention
- Being tested
- Rectal formulation (RF) of tenofovir 1% gel, Vaginal formulation (VF) of tenofovir 1% gel, Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel, Radiolabeling of study drugs and semen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal formulation (RF) of tenofovir 1% gelDrug
The RF is translucent colorless viscous gel formulation containing 1% (w/w) of tenofovir (PMPA) formulated in purified water with EDTA, glycerin, methylparaben, propylparaben, carbopol, sodium carboxy methyl cellulose, and pH adjusted to 7. The RF is close to isoosmolar with an osmolality of 479 mOsmol/kg.
Vaginal formulation (VF) of tenofovir 1% gelDrug
The original VF is a transparent, viscous gel formulation containing 1% (weight/ weight or w/w) of tenofovir (PMPA, 9-[(R)-2-(phosphonomethoxy)propyl]adenine monohydrate), formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben, hydroxyethylcellulose, and pH adjusted to 4-5. This formulation has been used in all clinical trials (vaginal, penile, and rectal) of tenofovir 1% gel to date.
Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gelDrug
Modified slightly from the original VF formulation, the RGVF has a lower glycerin content than the VF and a significantly reduced osmolality (836 or 846 versus 3111 mOsmol/kg). Lowering glycerin content lowered the viscosity, so the HEC concentration was increased by 10% (a change considered to be insignificant). The amount of parabens was increased by 10% each to improve the antimicrobical effectiveness. The RGVF formulation with 2.75% HEC was used in MTN-007 (CONRAD IND 73,382; currently enrolling), which is the only clinical study of this formulation. The RGVF formulation has since been modified to increase the viscosity.
Radiolabeling of study drugs and semenRadiation
Study products (i.e. the gel formulations) will be radiolabeled with 111In-DTPA, an FDA-approved radiopharmaceutical commonly used in diagnostic nuclear medicine studies. The delivered dose per gel study product will be approximately 100 microCuries (µCi) to allow sufficient visualization for the imaging period.
Autologous whole semen collected from the participants at designated visits will be radiolabeled with a delivered dose of approximately 500 microCuries (µCi) of 99mTc-sulfur colloid, also an FDA-approved radiopharmaceutical commonly used in diagnostic nuclear studies. The study team at JHU has extensive experience administering these radiopharmaceuticals rectally. Both of these radiopharmaceuticals will be prepared and delivered by a commercial radiopharmacy and mixed by the study investigators with the respective gel and whole semen vehicles.
The study product and autologous whole semen will be loaded into calibrated syringes with luer lock adapter for dosing.
| Study group | Role | What they receive |
|---|---|---|
| Rectal specific formulation (RF) stage | Experimental | Each participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose. Receives: Drug: Rectal formulation (RF) of tenofovir 1% gel; Radiation: Radiolabeling of study drugs and semen |
| Vaginal formulation (VF) stage | Active comparator | Each participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose. Receives: Drug: Vaginal formulation (VF) of tenofovir 1% gel; Radiation: Radiolabeling of study drugs and semen |
| Reduced glycerin vaginal formulation (RGVF) stage | Active comparator | Each participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose. Receives: Drug: Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel; Radiation: Radiolabeling of study drugs and semen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events and/or abnormal laboratory values Grade 2 or higher
Grade 2 or higher clinical and laboratory adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies) will be used to assess safety.
Measured: Participants will be followed for the duration of study, an expected average of 12 weeks
Secondary outcomes (1)
Area Under Curve (AUC)
Pharmacokinetics (PK) measures will be evaluated as plasma tenofovir concentrations
Distribution/migration of product and whole semen (with and without Coital Dynamic Simulation or CDS) will be evaluated based on:
- Distribution of product radiolabel (111Indium DTPA) within the colonic lumen
- Distribution of whole semen radiolabel (99mTc-sulfur colloid) within the colonic lumen
And mucosal permeability (with and without CDS) will be measured via:
- PK in blood of product radiolabel (111Indium DTPA)
- Urine
Measured: 0.25hr, 0.5hr, 0.75hr, 1hr, 1.25hr, 1.5hr, 1.75hr, 2hr, 2.33hr, 2.66hr, 3hr, 3.5hr, 4hr, 8hr, 16hr, and 24hr post-dose at Visits 2,4,5,7,8, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ian McGowan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), CONRAD
- Responsible party
- Sponsor-investigator, Ian McGowan, University of Pittsburgh
- Investigators
- Craig Hendrix, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575418
- Sponsor's protocol ID
- CHARM-02
- Other IDs
- 5U19AI082637
- Status last verified
- May 2014
- First submitted
- 1 Mar 2012
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hiruy H, Fuchs EJ, Marzinke MA, Bakshi RP, Breakey JC, Aung WS, Manohar M, Yue C, Caffo BS, Du Y, Abebe KZ, Spiegel HM, Rohan LC, McGowan I, Hendrix CW. A Phase 1 Randomized, Blinded Comparison of the Pharmacokinetics and Colonic Distribution of Three Candidate Rectal Microbicide Formulations of Tenofovir 1% Gel with Simulated Unprotected Sex (CHARM-02). AIDS Res Hum Retroviruses. 2015 Nov;31(11):1098-108. doi: 10.1089/AID.2015.0098. Epub 2015 Aug 24.
PubMed 26227279
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Double-Blinded, Randomized, Pharmacokinetic and Safety Study of Three Rectally-Applied Tenofovir 1% Microbicide Gel Formulations
- ClinicalTrials.gov ID
- NCT01575418
- Acronym / sponsor ID
- CHARM-02
- Conditions
- HIV Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ian McGowanUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), CONRAD
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be enrolled.
Each participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rectal specific formulation (RF) stage | Experimental | Drug: Rectal formulation (RF) of tenofovir 1% gel, Radiation: Radiolabeling of study drugs and semenEach participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose. |
| Vaginal formulation (VF) stage | Active comparator | Drug: Vaginal formulation (VF) of tenofovir 1% gel, Radiation: Radiolabeling of study drugs and semenEach participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose. |
| Reduced glycerin vaginal formulation (RGVF) stage | Active comparator | Drug: Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel, Radiation: Radiolabeling of study drugs and semenEach participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ Age of 18 at screening
- Willing and able to communicate in English
- Willing and able to provide written informed consent to take part in the study
- Willing and able to provide adequate locator information
- Understands and agrees to local STI reporting requirements
Key exclusion criteria (13 listed)
- Significant colorectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic external hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation.)
- At screening: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. Note that HSV seropositivity with no active genital lesions is not an exclusion criterion, since treatment is not required. (Note: Allow one re-screening after documented treatment (30 days) in cases where urethral GC/CT identified at screening)
- At screening:
- Known allergic reaction to methylparaben, propylparaben, sorbic acid, glycerin, glycerol, tenofovir, or other components of the test articles
- Known HIV-infected partners
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 |
|---|---|---|
| Rectal formulation (RF) of tenofovir 1% gelThe RF is translucent colorless viscous gel formulation containing 1% (w/w) of tenofovir (PMPA) formulated in purified water with EDTA, glycerin, methylparaben, propylparaben, carbopol, sodium carboxy methyl cellulose, and pH adjusted to 7. The RF is close to isoosmolar with an osmolality of 479 mOsmol/kg. | Drug | Rectal specific formulation (RF) stage |
| Vaginal formulation (VF) of tenofovir 1% gelThe original VF is a transparent, viscous gel formulation containing 1% (weight/ weight or w/w) of tenofovir (PMPA, 9-[(R)-2-(phosphonomethoxy)propyl]adenine monohydrate), formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben, hydroxyethylcellulose, and pH adjusted to 4-5. This formulation has been used in all clinical trials (vaginal, penile, and rectal) of tenofovir 1% gel to date. | Drug | Vaginal formulation (VF) stage |
| Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gelModified slightly from the original VF formulation, the RGVF has a lower glycerin content than the VF and a significantly reduced osmolality (836 or 846 versus 3111 mOsmol/kg). Lowering glycerin content lowered the viscosity, so the HEC concentration was increased by 10% (a change considered to be insignificant). The amount of parabens was increased by 10% each to improve the antimicrobical effectiveness. The RGVF formulation with 2.75% HEC was used in MTN-007 (CONRAD IND 73,382; currently enrolling), which is the only clinical study of this formulation. The RGVF formulation has since been modified to increase the viscosity. | Drug | Reduced glycerin vaginal formulation (RGVF) stage |
| Radiolabeling of study drugs and semenStudy products (i.e. the gel formulations) will be radiolabeled with 111In-DTPA, an FDA-approved radiopharmaceutical commonly used in diagnostic nuclear medicine studies. The delivered dose per gel study product will be approximately 100 microCuries (µCi) to allow sufficient visualization for the imaging period. Autologous whole semen collected from the participants at designated visits will be radiolabeled with a delivered dose of approximately 500 microCuries (µCi) of 99mTc-sulfur colloid, also an FDA-approved radiopharmaceutical commonly used in diagnostic nuclear studies. The study team at JHU has extensive experience administering these radiopharmaceuticals rectally. Both of these radiopharmaceuticals will be prepared and delivered by a commercial radiopharmacy and mixed by the study investigators with the respective gel and whole semen vehicles. The study product and autologous whole semen will be loaded into calibrated syringes with luer lock adapter for dosing. | Radiation | Rectal specific formulation (RF) stage, Reduced glycerin vaginal formulation (RGVF) stage, Vaginal formulation (VF) stage |
Primary outcome
Occurrence of adverse events and/or abnormal laboratory values Grade 2 or higher
Time frame: Participants will be followed for the duration of study, an expected average of 12 weeks
Grade 2 or higher clinical and laboratory adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies) will be used to assess safety.
1 secondary outcome
Area Under Curve (AUC)
Time frame: 0.25hr, 0.5hr, 0.75hr, 1hr, 1.25hr, 1.5hr, 1.75hr, 2hr, 2.33hr, 2.66hr, 3hr, 3.5hr, 4hr, 8hr, 16hr, and 24hr post-dose at Visits 2,4,5,7,8, and 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 26227279Hiruy H, Fuchs EJ, Marzinke MA, Bakshi RP, Breakey JC, Aung WS, Manohar M, Yue C, Caffo BS, Du Y, Abebe KZ, Spiegel HM, Rohan LC, McGowan I, Hendrix CW. A Phase 1 Randomized, Blinded Comparison of the Pharmacokinetics and Colonic Distribution of Three Candidate Rectal Microbicide Formulations of Tenofovir 1% Gel with Simulated Unprotected Sex (CHARM-02). AIDS Res Hum Retroviruses. 2015 Nov;31(11):1098-108. doi: 10.1089/AID.2015.0098. Epub 2015 Aug 24.
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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.
Craig Hendrix, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rectal formulation (RF) of tenofovir 1% gel, Vaginal formulation (VF) of tenofovir 1% gel and Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel in people with HIV Prevention, run by Ian McGowan at 1 site in United States.
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 8 inclusion and 13 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of adverse events and/or abnormal laboratory values Grade 2 or higher (time frame: Participants will be followed for the duration of study, an expected average of 12 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 NCT01575418, 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 8 May 2014.