Opiate-related DisordersPhase 4NCT00315341
Starting Treatment With Agonist Replacement Therapies (START)
A Phase 4 study testing Buprenorphine/naloxone and Methadone in people with Opiate-related Disorders, run by University of California, Los Angeles at 9 sites in United States.
Trial summary
The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate-related Disorders
- What is being tested?
- Buprenorphine/naloxone and Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,269 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2006to Aug 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Were age 18 years or older,
- Met DSM-IV-TR criteria for opioid dependence,
- Were in good general health, or, in case of a medical/psychiatric condition requiring ongoing treatment, were under the care of a physician willing to continue participant's medical management and cooperate with study physicians,
- For female participants, use of one of the following acceptable methods of birth control:
- oral contraceptives
- barrier (diaphragm or condom) with spermicide
Show all 15Show fewer
- IUD
- intrauterine progesterone contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- contraceptive transdermal patch
- hormonal vaginal contraceptive ring
- surgical sterilization
- complete abstinence from sexual intercourse
- Able to read and verbalize understanding of the study and voluntarily sign study informed consent form.
Who cannot join
- ALT or AST values > 5 times the upper limit of normal as per testing laboratory range criteria,
- ALP values >3 times the upper limit of normal per testing laboratory criteria,
- Any documented past or present history of ascites, presence of esophageal or gastric varices, hepatic encephalopathy or other signs of significant liver disease as indicated by a Model for Endstage Liver Disease score (Kamath et al., 2001) of ≥11,
- Total bilirubin > 2.0 mg/dl (participants with documented Gilbert's syndrome were not excluded based on this criterion),
- Prothrombin time more than 3 seconds prolonged,
- Albumin level less than 2.5 g/dl,
Show all 37Show fewer
- Any cardiopathy or risk factor listed below without evidence of a normal ECG* with report performed within 6 months prior to first study medication dose,
- Congestive heart failure
- Left ventricular hypertrophy
- Bradycardia
- Hereditary QT prolongation
- Uncorrected electrolyte imbalance
- Concomitant medications that are known to have a risk of QT interval prolongation; refer to Appendix D for a list of medications.
- Note: The list was not all-inclusive.
- An ECG was abnormal if one or more of the following occurred:
- Significant ST segment abnormalities:
- ST segment elevations in two or more continuous leads of > 0.1 mV
- ST segment depression of greater than 1 mm that are flat or down-sloping at 80 msec after the J point ST segment abnormalities identified as "non-specific" are acceptable. If a potential participant's ECG indicated ST segment elevations or depression consistent with ischemia, the physician obtained a medical history of cardiac symptoms and referred the participant for evaluation.
- Conduction abnormalities:
- Mobitz II 2nd degree or 3rd degree heart block
- Atrial fibrillation, atrial flutter, or any non-sinus tachyarrhythmia
- Three or more consecutive ectopic ventricular complexes at a rate of > 100 per minute.
- QTc greater than 450 msec in men and 480 msec in women
- Repolarization abnormalities:
- Acute medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., unstable pancreatic, cardiovascular or renal disease, significant anemia)
- Known allergy or sensitivity to BUP, naloxone or MET or to any of the inactive ingredients in the study medications (including lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD\&C Yellow No.6 color, magnesium stearate, Acesulfame K sweetener)
- Known diagnosis of acute psychosis, severe depression or imminent suicide risk as determined via clinical interview by study physician or surrogates
- DSM-IV diagnosis of dependence on alcohol requiring immediate medical attention.
- DSM-IV diagnosis of dependence on benzodiazepines requiring immediate medical attention
- DSM-IV diagnosis of dependence on other depressants, or stimulants requiring immediate medical attention
- Participation in an investigational drug study within the past 30 days
- Treatment with MET, BUP/NX, or BUP for more than 15 of the past 30 days (illicit use of these medications is allowed)
- Pending legal action that could prohibit study participation
- Unable or unwilling to comply with study requirements
- Unable or unwilling to remain in the local area for duration of treatment
- Poor venous access such that venipuncture could not be accomplished from a vein in an extremity during eligibility
- Pregnant or lactating (females only)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Addiction Research & Treatment Corp
Brooklyn, New York, 11201
Hartford Dispensary
Hartford, Connecticut, 06120
Matrix Institute
Los Angeles, California, 90016
NET Steps
Philadelphia, Pennsylvania, 19137
CODA-Research
Portland, Oregon, 97214
Bi-Valley Medical Clinic INC.
Sacramento, California, 95816
BAART; Turk Street Clinic
San Francisco, California, 94102
Evergreen Treatment Services
Seattle, Washington, 98134
CT Counseling Centers
Waterbury, Connecticut, 06705
About this study
The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.
Read the detailed description
This is a randomized, open-label, multi-center, Phase 4 study to assess the changes in liver enzymes related to treatment with buprenorphine/naloxone (BUP/NX) and methadone (MET) in participants entering opioid agonist treatment. Randomization will be stratified, within site, according to normal versus abnormal screening liver function tests. Participants meeting entry criteria will be dosed for 24 weeks during the active phase of the study with assessment of liver function at weeks 1, 2, 4, 8, 12, 16, 20, 24 and with follow-up assessments at week 32. Clinicians will be encouraged to treat with adequate doses of BUP/NX and MET.
- Conditions
- Opiate-related Disorders
- Being tested
- Buprenorphine/naloxone, Methadone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/naloxoneDrug
Participants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need.
MethadoneDrug
Participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine/Nx | Experimental | For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens. Receives: Drug: Buprenorphine/naloxone |
| Methadone | Active comparator | For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens. Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Safety
Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner:
A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study
B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN
C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN
D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Opiate-related DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 1,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Walter Ling, University of California, Los Angeles
- Investigators
- Walter Ling, M.D., Principal investigator, University of California, Los AngelesAndrew Saxon, M.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315341
- Sponsor's protocol ID
- NIDA-CTN-0027
- Other IDs
- U10DA013045
- Status last verified
- Nov 2016
- First submitted
- 16 Apr 2006
- Last updated
- 6 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Saxon AJ, Ling W, Hillhouse M, Thomas C, Hasson A, Ang A, Doraimani G, Tasissa G, Lokhnygina Y, Leimberger J, Bruce RD, McCarthy J, Wiest K, McLaughlin P, Bilangi R, Cohen A, Woody G, Jacobs P. Buprenorphine/Naloxone and methadone effects on laboratory indices of liver health: a randomized trial. Drug Alcohol Depend. 2013 Feb 1;128(1-2):71-6. doi: 10.1016/j.drugalcdep.2012.08.002. Epub 2012 Aug 22.
PubMed 22921476Brandt L, Odom GJ, Hu MC, Castro C, Balise RR; CTN-0094 Team. Empirically contrasting urine drug screening-based opioid use disorder treatment outcome definitions. Addiction. 2024 Jul;119(7):1289-1300. doi: 10.1111/add.16494. Epub 2024 Apr 14.
PubMed 38616571Wang K, Shafique S, Xiao D, Walter SM, Liu Y, Piamjariyakul U, Xie C. Repeated measures analysis of opioid use disorder treatment on clinical opiate withdrawal scale in a randomized clinical trial: sex differences. J Addict Dis. 2024 Jan-Mar;42(1):33-44. doi: 10.1080/10550887.2022.2131957. Epub 2023 Jan 19.
PubMed 36655851Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
PubMed 36063082Nwabueze C, Elom H, Liu S, Walter SM, Sha Z, Acevedo P, Liu Y, Su BB, Xu C, Piamjariyakul U, Wang K. Gender differences in the associations of multiple psychiatric and chronic conditions with major depressive disorder among patients with opioid use disorder. J Addict Dis. 2022 Apr-Jun;40(2):168-178. doi: 10.1080/10550887.2021.1957639. Epub 2021 Jul 30.
PubMed 34328394Crist RC, Li J, Doyle GA, Gilbert A, Dechairo BM, Berrettini WH. Pharmacogenetic analysis of opioid dependence treatment dose and dropout rate. Am J Drug Alcohol Abuse. 2018;44(4):431-440. doi: 10.1080/00952990.2017.1420795. Epub 2018 Jan 15.
PubMed 29333880Woody GE, Bruce D, Korthuis PT, Chhatre S, Poole S, Hillhouse M, Jacobs P, Sorensen J, Saxon AJ, Metzger D, Ling W. HIV risk reduction with buprenorphine-naloxone or methadone: findings from a randomized trial. J Acquir Immune Defic Syndr. 2014 Jul 1;66(3):288-93. doi: 10.1097/QAI.0000000000000165.
PubMed 24751432Hser YI, Saxon AJ, Huang D, Hasson A, Thomas C, Hillhouse M, Jacobs P, Teruya C, McLaughlin P, Wiest K, Cohen A, Ling W. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2014 Jan;109(1):79-87. doi: 10.1111/add.12333. Epub 2013 Oct 9.
PubMed 23961726
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting Treatment With Agonist Replacement Therapies (START)
- ClinicalTrials.gov ID
- NCT00315341
- Acronym / sponsor ID
- NIDA-CTN-0027
- Conditions
- Opiate-related Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,269 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.
Detailed description
This is a randomized, open-label, multi-center, Phase 4 study to assess the changes in liver enzymes related to treatment with buprenorphine/naloxone (BUP/NX) and methadone (MET) in participants entering opioid agonist treatment. Randomization will be stratified, within site, according to normal versus abnormal screening liver function tests. Participants meeting entry criteria will be dosed for 24 weeks during the active phase of the study with assessment of liver function at weeks 1, 2, 4, 8, 12, 16, 20, 24 and with follow-up assessments at week 32. Clinicians will be encouraged to treat with adequate doses of BUP/NX and MET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine/Nx | Experimental | Drug: Buprenorphine/naloxoneFor the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens. |
| Methadone | Active comparator | Drug: MethadoneFor the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Were age 18 years or older,
- Met DSM-IV-TR criteria for opioid dependence,
- Were in good general health, or, in case of a medical/psychiatric condition requiring ongoing treatment, were under the care of a physician willing to continue participant's medical management and cooperate with study physicians,
- For female participants, use of one of the following acceptable methods of birth control:
- Able to read and verbalize understanding of the study and voluntarily sign study informed consent form.
Key exclusion criteria (37 listed)
- ALT or AST values > 5 times the upper limit of normal as per testing laboratory range criteria,
- ALP values >3 times the upper limit of normal per testing laboratory criteria,
- Any documented past or present history of ascites, presence of esophageal or gastric varices, hepatic encephalopathy or other signs of significant liver disease as indicated by a Model for Endstage Liver Disease score (Kamath et al., 2001) of ≥11,
- Total bilirubin > 2.0 mg/dl (participants with documented Gilbert's syndrome were not excluded based on this criterion),
- Prothrombin time more than 3 seconds prolonged,
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 |
|---|---|---|
| Buprenorphine/naloxoneParticipants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need. | Drug | Buprenorphine/Nx |
| MethadoneParticipants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit. | Drug | Methadone |
Primary outcome
Hepatic Safety
Time frame: 24 Weeks
Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner: A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22921476Saxon AJ, Ling W, Hillhouse M, Thomas C, Hasson A, Ang A, Doraimani G, Tasissa G, Lokhnygina Y, Leimberger J, Bruce RD, McCarthy J, Wiest K, McLaughlin P, Bilangi R, Cohen A, Woody G, Jacobs P. Buprenorphine/Naloxone and methadone effects on laboratory indices of liver health: a randomized trial. Drug Alcohol Depend. 2013 Feb 1;128(1-2):71-6. doi: 10.1016/j.drugalcdep.2012.08.002. Epub 2012 Aug 22.
- Derived from this study: PubMed 38616571Brandt L, Odom GJ, Hu MC, Castro C, Balise RR; CTN-0094 Team. Empirically contrasting urine drug screening-based opioid use disorder treatment outcome definitions. Addiction. 2024 Jul;119(7):1289-1300. doi: 10.1111/add.16494. Epub 2024 Apr 14.
- Derived from this study: PubMed 36655851Wang K, Shafique S, Xiao D, Walter SM, Liu Y, Piamjariyakul U, Xie C. Repeated measures analysis of opioid use disorder treatment on clinical opiate withdrawal scale in a randomized clinical trial: sex differences. J Addict Dis. 2024 Jan-Mar;42(1):33-44. doi: 10.1080/10550887.2022.2131957. Epub 2023 Jan 19.
- Derived from this study: PubMed 36063082Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
- Derived from this study: PubMed 34328394Nwabueze C, Elom H, Liu S, Walter SM, Sha Z, Acevedo P, Liu Y, Su BB, Xu C, Piamjariyakul U, Wang K. Gender differences in the associations of multiple psychiatric and chronic conditions with major depressive disorder among patients with opioid use disorder. J Addict Dis. 2022 Apr-Jun;40(2):168-178. doi: 10.1080/10550887.2021.1957639. Epub 2021 Jul 30.
- Derived from this study: PubMed 29333880Crist RC, Li J, Doyle GA, Gilbert A, Dechairo BM, Berrettini WH. Pharmacogenetic analysis of opioid dependence treatment dose and dropout rate. Am J Drug Alcohol Abuse. 2018;44(4):431-440. doi: 10.1080/00952990.2017.1420795. Epub 2018 Jan 15.
- Derived from this study: PubMed 24751432Woody GE, Bruce D, Korthuis PT, Chhatre S, Poole S, Hillhouse M, Jacobs P, Sorensen J, Saxon AJ, Metzger D, Ling W. HIV risk reduction with buprenorphine-naloxone or methadone: findings from a randomized trial. J Acquir Immune Defic Syndr. 2014 Jul 1;66(3):288-93. doi: 10.1097/QAI.0000000000000165.
- Derived from this study: PubMed 23961726Hser YI, Saxon AJ, Huang D, Hasson A, Thomas C, Hillhouse M, Jacobs P, Teruya C, McLaughlin P, Wiest K, Cohen A, Ling W. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2014 Jan;109(1):79-87. doi: 10.1111/add.12333. Epub 2013 Oct 9.
- Individual participant dataSharing planned: No
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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.
Walter Ling, M.D. principal investigator
University of California, Los Angeles
Andrew Saxon, M.D. principal investigator
University of Washington
9 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 Buprenorphine/naloxone and Methadone in people with Opiate-related Disorders, run by University of California, Los Angeles at 9 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 15 inclusion and 37 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 6 Jan 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?
Hepatic Safety (time frame: 24 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 NCT00315341, which also lists 8 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 6 Jan 2017.