GonorrhoeaPhase 4NCT00926796
Efficacy of Combination Therapies for Gonorrhea Treatment
A Phase 4 study testing Azithromycin, Gentamicin and Gemifloxacin in people with Gonorrhoea, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However, some gonorrhea is not cured with a single antibiotic. The study will look at how well treating gonorrhea with 2 antibiotics works. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Gonorrhoea
- What is being tested?
- Azithromycin, Gentamicin and Gemifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2010to May 2013
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female from 15 - 60 years old.
- Is either:
- Untreated male or female with urethral or cervical gonorrhea as determined by a screening laboratory test [either Nucleic Acid Amplification Test (NAAT) or culture] for Neisseria gonorrhoeae at a prior visit.
- Urethral or cervical gram stain demonstrating gram negative intracellular diplococci and leukocytes.
- Untreated male or female who is a sexual contact (anal, oral, or vaginal) of an individual with gonorrhea in the past 60 days.
- Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until follow up is completed.
Show all 9Show fewer
- Willing to follow up from 10 to 17 days following enrollment.
- Willing to provide written consent.
- Able to swallow pills.
Who cannot join
- Known renal insufficiency from clinical history
- Known hepatic insufficiency from clinical history
- Known QT interval prolongation from clinical history
- Known neuromuscular disorder from clinical history (i.e., myasthenia gravis or Parkinson's disease)
- Known rheumatoid arthritis or tendon disorders from clinical history
- Known kidney, heart, or lung transplants from clinical history
Show all 17Show fewer
- Pregnant women (determined by positive urine pregnancy test)
- Breastfeeding women
- Known allergy or adverse reaction to macrolides, aminoglycosides, or quinolones
- Concomitant infection (besides chlamydia or bacterial vaginosis) which requires systemic antibiotics
- Has received systemic or intravaginal antibiotics within 30 days of study enrollment
- Currently taking corticosteroid drugs or other immunosuppressive therapy
- Currently taking cardiac antiarrhythmia drugs
- Self report of or clinical diagnosis of abdominal pain, pelvic inflammatory disease (PID), testicular pain, epididymitis, or disseminated gonococcal infection
- Self report of or clinical diagnosis of current genital ulcer (GU)
- In the judgment of the interviewer, has a medical condition or other factor that might affect their ability to follow the protocol
- Previous enrollment in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Bayview Medical Center - Infectious Diseases
Baltimore, Maryland, 21224-2735
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, 35249-0001
Los Angeles County Department of Public Health - Sexually Transmitted Disease Program
Los Angeles, California, 90007-2608
Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research
Pittsburgh, Pennsylvania, 15213-3108
San Francisco Department of Public Health - San Francisco City Clinic
San Francisco, California, 94103-4030
About this study
Official title: Randomized Clinical Trial Evaluating the Efficacy of Gentamicin/Azithromycin and Gemifloxacin/Azithromycin Combination Therapies as an Alternative Regimen for Uncomplicated Urogenital Gonorrhea
The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However, some gonorrhea is not cured with a single antibiotic. The study will look at how well treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2 treatment groups each receiving a combination of 2 antibiotics. Sites in the United States will recruit 500 male and female participants. Participants must be 15 to 60 years old, in good health and identified in participating sexually transmitted disease clinics as having uncomplicated cervical or urethral gonorrhea. Procedures include collection of current symptoms, medical and sexual history, sexual orientation, vital signs, height, weight, cervical/urethral cultures and clinical examinations. Volunteers will be involved for about 17 days.
Read the detailed description
Infection with Neisseria (N.) gonorrhoeae carries a significant public health burden in the United States (U.S.). Gonococcal infection can result in pelvic inflammatory disease (PID), ectopic pregnancy, infertility, chronic pelvic pain, and increases the risk of transmission and acquisition of human immunodeficiency virus (HIV). With over 350,000 cases of gonorrhea reported each year, gonorrhea is the second most common notifiable condition. Furthermore, it is estimated that case reports account for only half of the incident cases of gonorrhea in the U.S. each year. Given that gonorrhea is a bacterial infection which causes symptoms in approximately 90 percent of infected men and 50 percent of infected women, the most critical aspect of reducing the public health burden of gonorrhea for affected populations is provision of effective antimicrobial therapy. In order to identify treatment options for patients with suspect or confirmed cephalosporin-resistant N. gonorrhoeae infection and patients with severe cephalosporin hypersensitivity, this study plans to determine the efficacy of each of 2 combination antimicrobial regimens for the treatment of uncomplicated gonococcal infection. This study is a multicenter clinical trial of adult males and females diagnosed with urethral or cervical gonococcal infection. Subjects will be enrolled and randomized for treatment with either Regimen A: gentamicin 240 mg intramuscular (IM) one time for patients >45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth (PO) one time, or Regimen B: gemifloxacin 320 mg PO one time plus azithromycin 2 gm PO one time. Investigators hypothesize that Regimen A will have a clinical efficacy estimate that is greater than or equal to 95 percent as well as a lower, one-sided 95 percent confidence interval (CI 95 percent) bound that is greater than or equal to 90 percent. The identical hypothesis applies for Regimen B. It should be noted that this is not a comparative trial between Regimen A and B, but rather a trial to establish efficacy data for each of these two candidate regimens. The primary objective of this study is to determine the microbiological efficacy of each of two combination antimicrobial regimens for the treatment of uncomplicated gonococcal infection (i.e., non-systemic). Secondary objectives of this study are to: assess the safety and tolerability of each candidate regimen; assess the eradication of any rectal or pharyngeal gonococcal infection by each regimen; determine the antimicrobial susceptibility profile of all gonococcal strains isolated at the time of enrollment; determine the clinical and antimicrobial susceptibility profile of all gonococcal strains isolated from patients who fail treatment; and assess the efficacy of the candidate regimens on the resolution of symptoms and signs (clinical cure). The primary efficacy analysis will be based on microbiological cure rate at end of trial based on the modified intent-to-treat (MITT) and per protocol (PP) subsets. The number, percent, and a 95 percent one-sided (lower) confidence interval of microbiological cure rate successes and failures will be computed. Additional analyses will be conducted on the following subsets: male, female, men who have sex with men (MSM) status, and subjects denying anal, oral, or vaginal intercourse during the follow-up period. Secondary endpoints will include: separate analyses of: safety and tolerability of each regimen; eradication of rectal or pharyngeal infection; antimicrobial susceptibility profile of enrollment isolates; clinical and antimicrobial susceptibility profile of treatment failures; and resolution of
- Conditions
- Gonorrhoea
- Being tested
- Azithromycin, Gentamicin, Gemifloxacin
- Keywords
- gonorrhea, gonococcal infections, Neisseria gonorrhoeae
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Four 500 mg tablets will be administered orally to equal a 2 gm dose.
GentamicinDrug
Fixed dose of 240 mg intramuscular one time for patients >45 kg and a 5 mg/kg dose for patients less than or equal to 45 kg based on their measured weight in clinic. Most patients will require 2 injections of gentamicin in separate large muscle groups.
GemifloxacinDrug
One 320 mg tablet administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Regimen B: gemifloxacin plus azithromycin | Experimental | Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time. Receives: Drug: Azithromycin; Drug: Gemifloxacin |
| Regimen A: gentamicin plus azithromycin | Experimental | Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time. Receives: Drug: Azithromycin; Drug: Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)
Measured: 10-17 days after treatment.
Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)
Measured: 10-17 days after treatment.
Secondary outcomes (7)
Eradication of Rectal Infection
Number of enrollees with positive rectal culture at enrollment who have negative culture 10-17 days after treatment
Measured: 10-17 days after treatment.
Eradication of Pharyngeal Infection
Number of enrollees with positive pharyngeal culture at enrollment who have negative culture 10-17 days after treatment
Measured: 10-17 days after treatment.
Antimicrobial Susceptibility Profile of Treatment Failures.
For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), the minimum inhibitory concentrations for various antimicrobial agents (Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Gemifloxacin, Gentamicin, Penicillin, Tetracycline).
Measured: Isolates obtained at enrollment (Day 0).
Clinical Profile of Treatment Failures.
For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), number participants with clinical symptoms (vaginal/urethral discharge, dysuria, dyspareunia) at 10-17 days.
Measured: 10-17 days
Resolution of Symptoms and Signs (Clinical Cure)
Number of participants whose gonorrhea-related symptoms (e.g. vaginal/urethral discharge, dysuria, dyspareunia) present at enrollment has resolved by visit 2.
Measured: 10-17 days after treatment.
Antimicrobial Susceptibility Profile of Enrollment Isolates.
Minimum inhibitory concentration (micrograms/milliliter) of pretreatment gonorrhea isolates collected from participants
Measured: Isolates obtained at enrollment (Day 0).
Number of Participants With Adverse Events for Each Regimen
Number of treated participants experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product.
Measured: Day 0 through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionMay 2013
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 GonorrhoeaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926796
- Sponsor's protocol ID
- 08-0042
- Status last verified
- Jun 2013
- First submitted
- 23 Jun 2009
- Last updated
- 19 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kirkcaldy RD, Weinstock HS, Moore PC, Philip SS, Wiesenfeld HC, Papp JR, Kerndt PR, Johnson S, Ghanem KG, Hook EW 3rd. The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea. Clin Infect Dis. 2014 Oct 15;59(8):1083-91. doi: 10.1093/cid/ciu521. Epub 2014 Jul 16.
PubMed 25031289
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating the Efficacy of Gentamicin/Azithromycin and Gemifloxacin/Azithromycin Combination Therapies as an Alternative Regimen for Uncomplicated Urogenital Gonorrhea
- ClinicalTrials.gov ID
- NCT00926796
- Acronym / sponsor ID
- 08-0042
- Conditions
- Gonorrhoea
- Keywords
- gonorrhea, gonococcal infections, Neisseria gonorrhoeae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 20 Mar 2014
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 learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However, some gonorrhea is not cured with a single antibiotic. The study will look at how well treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2 treatment groups each receiving a combination of 2 antibiotics. Sites in the United States will recruit 500 male and female participants. Participants must be 15 to 60 years old, in good health and identified in participating sexually transmitted disease clinics as having uncomplicated cervical or urethral gonorrhea. Procedures include collection of current symptoms, medical and sexual history, sexual orientation, vital signs, height, weight, cervical/urethral cultures and clinical examinations. Volunteers will be involved for about 17 days.
Detailed description
Infection with Neisseria (N.) gonorrhoeae carries a significant public health burden in the United States (U.S.). Gonococcal infection can result in pelvic inflammatory disease (PID), ectopic pregnancy, infertility, chronic pelvic pain, and increases the risk of transmission and acquisition of human immunodeficiency virus (HIV). With over 350,000 cases of gonorrhea reported each year, gonorrhea is the second most common notifiable condition. Furthermore, it is estimated that case reports account for only half of the incident cases of gonorrhea in the U.S. each year. Given that gonorrhea is a bacterial infection which causes symptoms in approximately 90 percent of infected men and 50 percent of infected women, the most critical aspect of reducing the public health burden of gonorrhea for affected populations is provision of effective antimicrobial therapy. In order to identify treatment options for patients with suspect or confirmed cephalosporin-resistant N. gonorrhoeae infection and patients with severe cephalosporin hypersensitivity, this study plans to determine the efficacy of each of 2 combination antimicrobial regimens for the treatment of uncomplicated gonococcal infection. This study is a multicenter clinical trial of adult males and females diagnosed with urethral or cervical gonococcal infection. Subjects will be enrolled and randomized for treatment with either Regimen A: gentamicin 240 mg intramuscular (IM) one time for patients >45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth (PO) one time, or Regimen B: gemifloxacin 320 mg PO one time plus azithromycin 2 gm PO one time. Investigators hypothesize that Regimen A will have a clinical efficacy estimate that is greater than or equal to 95 percent as well as a lower, one-sided 95 percent confidence interval (CI 95 percent) bound that is greater than or equal to 90 percent. The identical hypothesis applies for Regimen B. It should be noted that this is not a comparative trial between Regimen A and B, but rather a trial to establish efficacy data for each of these two candidate regimens. The primary objective of this study is to determine the microbiological efficacy of each of two combination antimicrobial regimens for the treatment of uncomplicated gonococcal infection (i.e., non-systemic). Secondary objectives of this study are to: assess the safety and tolerability of each candidate regimen; assess the eradication of any rectal or pharyngeal gonococcal infection by each regimen; determine the antimicrobial susceptibility profile of all gonococcal strains isolated at the time of enrollment; determine the clinical and antimicrobial susceptibility profile of all gonococcal strains isolated from patients who fail treatment; and assess the efficacy of the candidate regimens on the resolution of symptoms and signs (clinical cure). The primary efficacy analysis will be based on microbiological cure rate at end of trial based on the modified intent-to-treat (MITT) and per protocol (PP) subsets. The number, percent, and a 95 percent one-sided (lower) confidence interval of microbiological cure rate successes and failures will be computed. Additional analyses will be conducted on the following subsets: male, female, men who have sex with men (MSM) status, and subjects denying anal, oral, or vaginal intercourse during the follow-up period. Secondary endpoints will include: separate analyses of: safety and tolerability of each regimen; eradication of rectal or pharyngeal infection; antimicrobial susceptibility profile of enrollment isolates; clinical and antimicrobial susceptibility profile of treatment failures; and resolution of
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen B: gemifloxacin plus azithromycin | Experimental | Drug: Azithromycin, Drug: GemifloxacinGemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time. |
| Regimen A: gentamicin plus azithromycin | Experimental | Drug: Azithromycin, Drug: GentamicinGentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male or female from 15 - 60 years old.
- Is either:
- Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until follow up is completed.
- Willing to follow up from 10 to 17 days following enrollment.
- Willing to provide written consent.
Key exclusion criteria (17 listed)
- Known renal insufficiency from clinical history
- Known hepatic insufficiency from clinical history
- Known QT interval prolongation from clinical history
- Known neuromuscular disorder from clinical history (i.e., myasthenia gravis or Parkinson's disease)
- Known rheumatoid arthritis or tendon disorders from clinical history
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 |
|---|---|---|
| AzithromycinFour 500 mg tablets will be administered orally to equal a 2 gm dose. | Drug | Regimen A: gentamicin plus azithromycin, Regimen B: gemifloxacin plus azithromycin |
| GentamicinFixed dose of 240 mg intramuscular one time for patients >45 kg and a 5 mg/kg dose for patients less than or equal to 45 kg based on their measured weight in clinic. Most patients will require 2 injections of gentamicin in separate large muscle groups. | Drug | Regimen A: gentamicin plus azithromycin |
| GemifloxacinOne 320 mg tablet administered orally. | Drug | Regimen B: gemifloxacin plus azithromycin |
Primary outcome
Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
Time frame: 10-17 days after treatment.
Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)
Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection
Time frame: 10-17 days after treatment.
Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)
7 secondary outcomes
Eradication of Rectal Infection
Time frame: 10-17 days after treatment.
Eradication of Pharyngeal Infection
Time frame: 10-17 days after treatment.
Antimicrobial Susceptibility Profile of Treatment Failures.
Time frame: Isolates obtained at enrollment (Day 0).
Clinical Profile of Treatment Failures.
Time frame: 10-17 days
Resolution of Symptoms and Signs (Clinical Cure)
Time frame: 10-17 days after treatment.
Antimicrobial Susceptibility Profile of Enrollment Isolates.
Time frame: Isolates obtained at enrollment (Day 0).
Number of Participants With Adverse Events for Each Regimen
Time frame: Day 0 through Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25031289Kirkcaldy RD, Weinstock HS, Moore PC, Philip SS, Wiesenfeld HC, Papp JR, Kerndt PR, Johnson S, Ghanem KG, Hook EW 3rd. The efficacy and safety of gentamicin plus azithromycin and gemifloxacin plus azithromycin as treatment of uncomplicated gonorrhea. Clin Infect Dis. 2014 Oct 15;59(8):1083-91. doi: 10.1093/cid/ciu521. Epub 2014 Jul 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin, Gentamicin and Gemifloxacin in people with Gonorrhoea, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites 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 9 inclusion and 17 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 Mar 2014). 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?
Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection (time frame: 10-17 days after treatment.). The study lists 2 primary outcomes in all. 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 NCT00926796, 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 19 Aug 2015.