TuberculosisPhase 2High RIFNCT00760149
Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis
A Phase 2 study testing Rifampicin in higher doses in people with Tuberculosis, run by Radboud University Medical Center at 1 site in Tanzania.
Trial summary
In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of higher than standard doses rifampicin will be studied during the intensive phase of tuberculosis (TB) treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Rifampicin in higher doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2010to Sep 2013
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has a newly diagnosed pulmonary tuberculosis, confirmed by a positive smear of at least two sputum specimens with ZN staining.
- Participant is willing to be tested for HIV.
- Participant is at least 18, but not more than 65 years of age at the day of the first dosing of study medication.
- Participant is admitted to KNTH or KCMC during the intensive phase of TB treatment.
- Participant is able and willing to attend to KNTH or KCMC regularly during the continuation phase of TB treatment.
- Participant is able to understand and willing to sign the Informed Consent Form prior to screening evaluations.
- Female participants should understand that it is important not to get pregnant during the study. They should agree on taking measures to prevent them from getting pregnant during the study. They should agree on taking measures to prevent them from getting pregnant, such as using a contraceptive device or barrier method.
Who cannot join
- Participant has been treated with anti-tuberculosis drugs during the past three years.
- Participant's body weight is less than 50 kg.
- Participant has abnormal liver function test or serum creatinine (defined as levels higher than the upper limit of normal).
- Participant has a relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, Diabetes Mellitus, renal or hepatic disease, use of concomitant drugs that interfere with the pharmacokinetics of anti-TB drugs).
- Participant is on anti-retroviral treatment at inclusion.
- Participant has a CD4 count less than 350 cells/mm3.
Show all 9Show fewer
- Participant has a Karnofsky score of less than 40.
- Participant is pregnant or breastfeeding.
- Participant has a Multi Drug Resistant (MDR)-TB for which another than the standard treatment regimen is needed.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Kibong'oto National Tuberculosis Hospital
Sanya Juu, Kilimanjaro, P.O. box 12
About this study
Official title: Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania.
In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of higher than standard doses rifampicin will be studied during the intensive phase of tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid, ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin plus the other drugs in standard dosages (third study arm). All patients will get the standard TB regimen during the continuation phase of treatment.
- Conditions
- Tuberculosis
- Being tested
- Rifampicin in higher doses
- Keywords
- tuberculosis, rifampicin, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifampicin in higher dosesDrug
Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 50 patients, treated with the standard anti-TB regimen, including rifampicin (600 mg), isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 2 placebo tablets resembling rifampicin 300 mg. Receives: Drug: Rifampicin in higher doses |
| 2 | Active comparator | 50 patients, treated with rifampicin (900 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 1 placebo tablet resembling rifampicin 300 mg. Receives: Drug: Rifampicin in higher doses |
| 3 | Active comparator | 50 patients, treated with rifampicin (1200 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. Receives: Drug: Rifampicin in higher doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of rifampicin, desacetylrifampicin, isoniazid, pyrazinamide, ethambutol
Measured: Steady state, week 6
Secondary outcomes (4)
Occurrence of adverse events
Measured: baseline, week 1, 2, 4, 6, 8, 10, 12
Bacteriological response of Mycobacterium tuberculosis
Measured: Almost daily during first 8 weeks
Compare accuracy of surrogate markers (SSCC, mRNA, cytokines) with standard two-month sputum conversion marker
Measured: Almost daily during first 8 weeks
Documenting the occurrence of mixed Mycobacterium tuberculosis strain infections
Measured: Almost daily during first 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJul 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Sanofi, Kilimanjaro Christian Medical Centre, Tanzania, Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania, University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands, National Institute for Public Health and the Environment (RIVM)
- Investigators
- Rob Aarnoutse, Pharm-D, PhD, Principal investigator, Radboud University Medical CenterGibson Kibiki, MD, MMed, PhD, Principal investigator, Kilimanjaro Christian Medical Centre,Moshi,TanzaniaMartin Boeree, MD PhD, Principal investigator, Radboud University Nijmegen Medical Center/UCCZ Dekkerswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760149
- Sponsor's protocol ID
- APRIORI 4.1
- Other IDs
- PACTR2009060001493909
- Acronym
- High RIF
- Status last verified
- Sep 2013
- First submitted
- 25 Sep 2008
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frieden TR, Sterling TR, Munsiff SS, Watt CJ, Dye C. Tuberculosis. Lancet. 2003 Sep 13;362(9387):887-99. doi: 10.1016/S0140-6736(03)14333-4.
PubMed 13678977Iseman MD. Tuberculosis therapy: past, present and future. Eur Respir J Suppl. 2002 Jul;36:87s-94s. doi: 10.1183/09031936.02.00309102.
PubMed 12168751Ginsberg AM, Spigelman M. Challenges in tuberculosis drug research and development. Nat Med. 2007 Mar;13(3):290-4. doi: 10.1038/nm0307-290. No abstract available.
PubMed 17342142Mitchison DA. Role of individual drugs in the chemotherapy of tuberculosis. Int J Tuberc Lung Dis. 2000 Sep;4(9):796-806.
PubMed 10985648Diacon AH, Patientia RF, Venter A, van Helden PD, Smith PJ, McIlleron H, Maritz JS, Donald PR. Early bactericidal activity of high-dose rifampin in patients with pulmonary tuberculosis evidenced by positive sputum smears. Antimicrob Agents Chemother. 2007 Aug;51(8):2994-6. doi: 10.1128/AAC.01474-06. Epub 2007 May 21.
PubMed 17517849Jayaram R, Gaonkar S, Kaur P, Suresh BL, Mahesh BN, Jayashree R, Nandi V, Bharat S, Shandil RK, Kantharaj E, Balasubramanian V. Pharmacokinetics-pharmacodynamics of rifampin in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother. 2003 Jul;47(7):2118-24. doi: 10.1128/AAC.47.7.2118-2124.2003.
PubMed 12821456Kreis B, Pretet S, Birenbaum J, Guibout P, Hazeman JJ, Orin E, Perdrizet S, Weil J. Two three-month treatment regimens for pulmonary tuberculosis. Bull Int Union Tuberc. 1976;51(1):71-5. No abstract available.
PubMed 1030315Long MW, Snider DE Jr, Farer LS. U.S. Public Health Service Cooperative trial of three rifampin-isoniazid regimens in treatment of pulmonary tuberculosis. Am Rev Respir Dis. 1979 Jun;119(6):879-94. doi: 10.1164/arrd.1979.119.6.879.
PubMed 110184Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001;40(5):327-41. doi: 10.2165/00003088-200140050-00002.
PubMed 11432536Ruslami R, Nijland HM, Alisjahbana B, Parwati I, van Crevel R, Aarnoutse RE. Pharmacokinetics and tolerability of a higher rifampin dose versus the standard dose in pulmonary tuberculosis patients. Antimicrob Agents Chemother. 2007 Jul;51(7):2546-51. doi: 10.1128/AAC.01550-06. Epub 2007 Apr 23.
PubMed 17452486Ruslami R, Nijland H, Aarnoutse R, Alisjahbana B, Soeroto AY, Ewalds S, van Crevel R. Evaluation of high- versus standard-dose rifampin in Indonesian patients with pulmonary tuberculosis. Antimicrob Agents Chemother. 2006 Feb;50(2):822-3. doi: 10.1128/AAC.50.2.822-823.2006. No abstract available.
PubMed 16436757Solera J, Rodriguez-Zapata M, Geijo P, Largo J, Paulino J, Saez L, Martinez-Alfaro E, Sanchez L, Sepulveda MA, Ruiz-Ribo MD. Doxycycline-rifampin versus doxycycline-streptomycin in treatment of human brucellosis due to Brucella melitensis. The GECMEI Group. Grupo de Estudio de Castilla-la Mancha de Enfermedades Infecciosas. Antimicrob Agents Chemother. 1995 Sep;39(9):2061-7. doi: 10.1128/AAC.39.9.2061.
PubMed 8540716Kochar DK, Aseri S, Sharma BV, Bumb RA, Mehta RD, Purohit SK. The role of rifampicin in the management of cutaneous leishmaniasis. QJM. 2000 Nov;93(11):733-7. doi: 10.1093/qjmed/93.11.733.
PubMed 11077029Rosenthal IM, Williams K, Tyagi S, Peloquin CA, Vernon AA, Bishai WR, Grosset JH, Nuermberger EL. Potent twice-weekly rifapentine-containing regimens in murine tuberculosis. Am J Respir Crit Care Med. 2006 Jul 1;174(1):94-101. doi: 10.1164/rccm.200602-280OC. Epub 2006 Mar 30.
PubMed 16574936Fox W, Ellard GA, Mitchison DA. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council tuberculosis units, 1946-1986, with relevant subsequent publications. Int J Tuberc Lung Dis. 1999 Oct;3(10 Suppl 2):S231-79. No abstract available.
PubMed 10529902
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania.
- ClinicalTrials.gov ID
- NCT00760149
- Acronym / sponsor ID
- High RIF / APRIORI 4.1
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, rifampicin, pharmacokinetics, pharmacodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Sanofi, Kilimanjaro Christian Medical Centre, Tanzania, Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania, University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands, National Institute for Public Health and the Environment (RIVM)
- Study start
- Jul 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Sep 2008 (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.
In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of higher than standard doses rifampicin will be studied during the intensive phase of tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid, ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin plus the other drugs in standard dosages (third study arm). All patients will get the standard TB regimen during the continuation phase of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Rifampicin in higher doses50 patients, treated with the standard anti-TB regimen, including rifampicin (600 mg), isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 2 placebo tablets resembling rifampicin 300 mg. |
| 2 | Active comparator | Drug: Rifampicin in higher doses50 patients, treated with rifampicin (900 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. In addition they will receive 1 placebo tablet resembling rifampicin 300 mg. |
| 3 | Active comparator | Drug: Rifampicin in higher doses50 patients, treated with rifampicin (1200 mg), and the other drugs in standard dosages (isoniazid (300 mg), pyrazinamide (30 mg/kg), ethambutol (15 mg/kg)), administered daily, orally, during the intensive phase of TB treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has a newly diagnosed pulmonary tuberculosis, confirmed by a positive smear of at least two sputum specimens with ZN staining.
- Participant is willing to be tested for HIV.
- Participant is at least 18, but not more than 65 years of age at the day of the first dosing of study medication.
- Participant is admitted to KNTH or KCMC during the intensive phase of TB treatment.
- Participant is able and willing to attend to KNTH or KCMC regularly during the continuation phase of TB treatment.
Key exclusion criteria (9 listed)
- Participant has been treated with anti-tuberculosis drugs during the past three years.
- Participant's body weight is less than 50 kg.
- Participant has abnormal liver function test or serum creatinine (defined as levels higher than the upper limit of normal).
- Participant has a relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, Diabetes Mellitus, renal or hepatic disease, use of concomitant drugs that interfere with the pharmacokinetics of anti-TB drugs).
- Participant is on anti-retroviral treatment at inclusion.
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 |
|---|---|---|
| Rifampicin in higher dosesRifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3) | Drug | 1, 2, 3 |
Primary outcome
Pharmacokinetic parameters of rifampicin, desacetylrifampicin, isoniazid, pyrazinamide, ethambutol
Time frame: Steady state, week 6
4 secondary outcomes
Occurrence of adverse events
Time frame: baseline, week 1, 2, 4, 6, 8, 10, 12
Bacteriological response of Mycobacterium tuberculosis
Time frame: Almost daily during first 8 weeks
Compare accuracy of surrogate markers (SSCC, mRNA, cytokines) with standard two-month sputum conversion marker
Time frame: Almost daily during first 8 weeks
Documenting the occurrence of mixed Mycobacterium tuberculosis strain infections
Time frame: Almost daily during first 8 weeks
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 9 Sep 2013.
- Background: PubMed 13678977Frieden TR, Sterling TR, Munsiff SS, Watt CJ, Dye C. Tuberculosis. Lancet. 2003 Sep 13;362(9387):887-99. doi: 10.1016/S0140-6736(03)14333-4.
- Background: PubMed 12168751Iseman MD. Tuberculosis therapy: past, present and future. Eur Respir J Suppl. 2002 Jul;36:87s-94s. doi: 10.1183/09031936.02.00309102.
- Background: PubMed 17342142Ginsberg AM, Spigelman M. Challenges in tuberculosis drug research and development. Nat Med. 2007 Mar;13(3):290-4. doi: 10.1038/nm0307-290. No abstract available.
- Background: PubMed 10985648Mitchison DA. Role of individual drugs in the chemotherapy of tuberculosis. Int J Tuberc Lung Dis. 2000 Sep;4(9):796-806.
- Background: PubMed 17517849Diacon AH, Patientia RF, Venter A, van Helden PD, Smith PJ, McIlleron H, Maritz JS, Donald PR. Early bactericidal activity of high-dose rifampin in patients with pulmonary tuberculosis evidenced by positive sputum smears. Antimicrob Agents Chemother. 2007 Aug;51(8):2994-6. doi: 10.1128/AAC.01474-06. Epub 2007 May 21.
- Background: PubMed 12821456Jayaram R, Gaonkar S, Kaur P, Suresh BL, Mahesh BN, Jayashree R, Nandi V, Bharat S, Shandil RK, Kantharaj E, Balasubramanian V. Pharmacokinetics-pharmacodynamics of rifampin in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother. 2003 Jul;47(7):2118-24. doi: 10.1128/AAC.47.7.2118-2124.2003.
- Background: PubMed 1030315Kreis B, Pretet S, Birenbaum J, Guibout P, Hazeman JJ, Orin E, Perdrizet S, Weil J. Two three-month treatment regimens for pulmonary tuberculosis. Bull Int Union Tuberc. 1976;51(1):71-5. No abstract available.
- Background: PubMed 110184Long MW, Snider DE Jr, Farer LS. U.S. Public Health Service Cooperative trial of three rifampin-isoniazid regimens in treatment of pulmonary tuberculosis. Am Rev Respir Dis. 1979 Jun;119(6):879-94. doi: 10.1164/arrd.1979.119.6.879.
- Background: PubMed 11432536Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001;40(5):327-41. doi: 10.2165/00003088-200140050-00002.
- Background: PubMed 17452486Ruslami R, Nijland HM, Alisjahbana B, Parwati I, van Crevel R, Aarnoutse RE. Pharmacokinetics and tolerability of a higher rifampin dose versus the standard dose in pulmonary tuberculosis patients. Antimicrob Agents Chemother. 2007 Jul;51(7):2546-51. doi: 10.1128/AAC.01550-06. Epub 2007 Apr 23.
- Background: PubMed 16436757Ruslami R, Nijland H, Aarnoutse R, Alisjahbana B, Soeroto AY, Ewalds S, van Crevel R. Evaluation of high- versus standard-dose rifampin in Indonesian patients with pulmonary tuberculosis. Antimicrob Agents Chemother. 2006 Feb;50(2):822-3. doi: 10.1128/AAC.50.2.822-823.2006. No abstract available.
- Background: PubMed 8540716Solera J, Rodriguez-Zapata M, Geijo P, Largo J, Paulino J, Saez L, Martinez-Alfaro E, Sanchez L, Sepulveda MA, Ruiz-Ribo MD. Doxycycline-rifampin versus doxycycline-streptomycin in treatment of human brucellosis due to Brucella melitensis. The GECMEI Group. Grupo de Estudio de Castilla-la Mancha de Enfermedades Infecciosas. Antimicrob Agents Chemother. 1995 Sep;39(9):2061-7. doi: 10.1128/AAC.39.9.2061.
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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.
Rob Aarnoutse, Pharm-D, PhD principal investigator
Radboud University Medical Center
Gibson Kibiki, MD, MMed, PhD principal investigator
Kilimanjaro Christian Medical Centre,Moshi,Tanzania
Martin Boeree, MD PhD principal investigator
Radboud University Nijmegen Medical Center/UCCZ Dekkerswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifampicin in higher doses in people with Tuberculosis, run by Radboud University Medical Center at 1 site in Tanzania.
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 9 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 9 Sep 2013. 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 Tanzania. 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?
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?
Pharmacokinetic parameters of rifampicin, desacetylrifampicin, isoniazid, pyrazinamide, ethambutol (time frame: Steady state, week 6). 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 NCT00760149, which also lists 38 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 9 Sep 2013.