Opiate DependencePhase 4NCT00604188
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
A Phase 4 study testing Suboxone (SCH 000484) and Subutex (SCH 028444) in people with Opiate Dependence and Drug Dependence, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Opiate Dependence, Drug Dependence, Substance Dependence
- What is being tested?
- Suboxone (SCH 000484) and Subutex (SCH 028444)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2008to 10 Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must be males or non-pregnant, non-lactating females.
- Participants must be at least 15 years of age, of either sex, and any race.
- Participants (and/or the parent or guardian for participants under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- Participants must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence.
- Participants must have a methadone- and buprenorphine-negative UDS result prior to randomization.
- Each participant must confirm that he or she is practicing adequate contraception. Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or must be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who have been postmenopausal for >=1 year (ie, women who have experienced 12 or more consecutive months of amenorrhea) will be exempted from the requirement to use contraception during the study. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device, oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation).
- Female participants of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) test prior to enrollment in the study
Who cannot join
- Participants for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling.
- Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
- Participants who are participating in any other clinical study in which medication(s) are being delivered.
- Participants with known allergy or sensitivity to buprenorphine or naloxone.
- Participants who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
- Participants with serious untreated Axis I DSM-IV-TR psychiatric co-morbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude participants except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification.
- HIV-positive participants with clinical acquired immunodeficiency syndrome (AIDS).
- Methadone or buprenorphine maintenance or detoxification within 30 days of enrollment.
About this study
Official title: A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone.
Read the detailed description
Rationale: Once Suboxone becomes available for widespread clinical use, it is anticipated that opioid-dependent patients seeking treatment with buprenorphine will be placed directly onto Suboxone. Two strategies that have had good success for inducting patients onto Suboxone have been developed: 1) a "bridging" procedure in which patients initiate therapy with Subutex and then transfer to Suboxone, and 2) a direct Suboxone induction procedure. However, there have been no controlled studies of direct Suboxone induction, and it is not clear whether using a Subutex-to-Suboxone induction procedure would produce any added clinical benefit for the patient relative to direct Suboxone induction.
This study addresses a post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of induction with Suboxone. Using a prospective, randomized, active-drug-controlled, double-blind and double-dummy design, this study will assess the acceptability and safety of Suboxone in heroin users by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone. The dose regimen used during the induction phase of this study is identical to that used in the pivotal efficacy study comparing Suboxone and Subutex (Fudala et al, 2003), which is included in the Suboxone Summary of Product Characteristics. The data collected in this study will include information on the extent of opioid use before treatment initiation.
Two strategies for inducting opioid-dependent patients using short-acting opioids (eg, heroin) onto Suboxone have emerged from published US studies. One involves using Subutex to "bridge" the transition to Suboxone by using Subutex over the first 2 days before transferring directly to Suboxone on the third day. The other involves direct Suboxone induction, in which patients receive Suboxone as the initial dose followed by continued rapid Suboxone dose titration.
In the pivotal efficacy study, opiate-dependent heroin users assigned to either Subutex or Suboxone groups received an induction dose of 8 mg of Subutex (administered as a single 8-mg tablet) on Day 1 and 16 mg of Subutex (administered as two 8-mg tablets) on Day 2. The 109 participants assigned to Suboxone received 16 mg of Suboxone (administered as two 8-mg tablets) on Day 3, and the 105 participants assigned to Subutex received 16 mg of Subutex (administered as two 8-mg tablets) on Day 3. The induction schedule used in the pivotal trial, in which a Subutex-to-Suboxone bridging procedure was used, was successful for inducting heroin-dependent patients onto Suboxone, achieving good compliance and resulting in relatively few AEs accounting for treatment discontinuation.
Overall, several large-scale studies using Suboxone as an initial medication have been conducted with good results, and it appears clear that, as was the case in the pivotal study, most patients safely tolerate a total dose of at least 8 mg on the first day of treatment. However, as these studies were not controlled, it remains unclear whether using a Subutex-to-Suboxone induction procedure would produce any added clinical benefit to the patient relative to a direct Suboxone induction procedure. Furthermore, there have been no studies of direct Suboxone induction outside of the United States.
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Being tested
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboxone (SCH 000484)Drug
Also called SCH 000484
2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
Subutex (SCH 028444)Drug
Also called SCH 028444
2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
| Study group | Role | What they receive |
|---|---|---|
| Direct Suboxone Induction | Experimental | Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day. Receives: Drug: Suboxone (SCH 000484) |
| Subutex-to-Suboxone Induction | Active comparator | Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day. Receives: Drug: Suboxone (SCH 000484); Drug: Subutex (SCH 028444) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders at Day 3
Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders.
All participants that continued the study received Suboxone tablets on Day 3.
Measured: 3 days
Secondary outcomes (7)
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28.
Measured: 28 days
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use.
Measured: Days 3 to 28
Self-reported Opioid Withdrawal Symptoms (SOWS)
SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28.
Measured: Baseline and 28 days
Observer-rated Opioid Withdrawal Symptoms (OOWS)
The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28.
Measured: Baseline and 28 days
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28.
The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis.
Measured: Baseline and 28 days
Compliance Rate
Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment.
Measured: 28 days
Responders at Day 28
Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study start22 Feb 2008
- Primary completion10 Dec 2009
- Study completion10 Dec 2009
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 Opiate DependenceStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604188
- Sponsor's protocol ID
- P05042
- Status last verified
- Jun 2017
- First submitted
- 17 Jan 2008
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Amass L, Pukeleviciene V, Subata E, Almeida AR, Pieri MC, D'Egidio P, Stankova Z, Costa A, Smyth BP, Sakoman S, Wei Y, Strang J. A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals. Addiction. 2012 Jan;107(1):142-51. doi: 10.1111/j.1360-0443.2011.03577.x. Epub 2011 Oct 12.
PubMed 21749526
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users
- ClinicalTrials.gov ID
- NCT00604188
- Acronym / sponsor ID
- P05042
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2008 (actual)
- Primary completion
- 10 Dec 2009 (actual)
- Study completion
- 10 Dec 2009 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 6 May 2011
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 assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone.
Detailed description
Rationale: Once Suboxone becomes available for widespread clinical use, it is anticipated that opioid-dependent patients seeking treatment with buprenorphine will be placed directly onto Suboxone. Two strategies that have had good success for inducting patients onto Suboxone have been developed: 1) a "bridging" procedure in which patients initiate therapy with Subutex and then transfer to Suboxone, and 2) a direct Suboxone induction procedure. However, there have been no controlled studies of direct Suboxone induction, and it is not clear whether using a Subutex-to-Suboxone induction procedure would produce any added clinical benefit for the patient relative to direct Suboxone induction.
This study addresses a post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of induction with Suboxone. Using a prospective, randomized, active-drug-controlled, double-blind and double-dummy design, this study will assess the acceptability and safety of Suboxone in heroin users by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone. The dose regimen used during the induction phase of this study is identical to that used in the pivotal efficacy study comparing Suboxone and Subutex (Fudala et al, 2003), which is included in the Suboxone Summary of Product Characteristics. The data collected in this study will include information on the extent of opioid use before treatment initiation.
Two strategies for inducting opioid-dependent patients using short-acting opioids (eg, heroin) onto Suboxone have emerged from published US studies. One involves using Subutex to "bridge" the transition to Suboxone by using Subutex over the first 2 days before transferring directly to Suboxone on the third day. The other involves direct Suboxone induction, in which patients receive Suboxone as the initial dose followed by continued rapid Suboxone dose titration.
In the pivotal efficacy study, opiate-dependent heroin users assigned to either Subutex or Suboxone groups received an induction dose of 8 mg of Subutex (administered as a single 8-mg tablet) on Day 1 and 16 mg of Subutex (administered as two 8-mg tablets) on Day 2. The 109 participants assigned to Suboxone received 16 mg of Suboxone (administered as two 8-mg tablets) on Day 3, and the 105 participants assigned to Subutex received 16 mg of Subutex (administered as two 8-mg tablets) on Day 3. The induction schedule used in the pivotal trial, in which a Subutex-to-Suboxone bridging procedure was used, was successful for inducting heroin-dependent patients onto Suboxone, achieving good compliance and resulting in relatively few AEs accounting for treatment discontinuation.
Overall, several large-scale studies using Suboxone as an initial medication have been conducted with good results, and it appears clear that, as was the case in the pivotal study, most patients safely tolerate a total dose of at least 8 mg on the first day of treatment. However, as these studies were not controlled, it remains unclear whether using a Subutex-to-Suboxone induction procedure would produce any added clinical benefit to the patient relative to a direct Suboxone induction procedure. Furthermore, there have been no studies of direct Suboxone induction outside of the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Suboxone Induction | Experimental | Drug: Suboxone (SCH 000484)Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day. |
| Subutex-to-Suboxone Induction | Active comparator | Drug: Suboxone (SCH 000484), Drug: Subutex (SCH 028444)Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be males or non-pregnant, non-lactating females.
- Participants must be at least 15 years of age, of either sex, and any race.
- Participants (and/or the parent or guardian for participants under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- Participants must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence.
- Participants must have a methadone- and buprenorphine-negative UDS result prior to randomization.
Key exclusion criteria (8 listed)
- Participants for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling.
- Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
- Participants who are participating in any other clinical study in which medication(s) are being delivered.
- Participants with known allergy or sensitivity to buprenorphine or naloxone.
- Participants who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
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 |
|---|---|---|
| Suboxone (SCH 000484)Also: SCH 0004842 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days | Drug | Direct Suboxone Induction, Subutex-to-Suboxone Induction |
| Subutex (SCH 028444)Also: SCH 0284442 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days | Drug | Subutex-to-Suboxone Induction |
Primary outcome
Responders at Day 3
Time frame: 3 days
Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders. All participants that continued the study received Suboxone tablets on Day 3.
7 secondary outcomes
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Time frame: 28 days
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Time frame: Days 3 to 28
Self-reported Opioid Withdrawal Symptoms (SOWS)
Time frame: Baseline and 28 days
Observer-rated Opioid Withdrawal Symptoms (OOWS)
Time frame: Baseline and 28 days
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Time frame: Baseline and 28 days
Compliance Rate
Time frame: 28 days
Responders at Day 28
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21749526Amass L, Pukeleviciene V, Subata E, Almeida AR, Pieri MC, D'Egidio P, Stankova Z, Costa A, Smyth BP, Sakoman S, Wei Y, Strang J. A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals. Addiction. 2012 Jan;107(1):142-51. doi: 10.1111/j.1360-0443.2011.03577.x. Epub 2011 Oct 12.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suboxone (SCH 000484) and Subutex (SCH 028444) in people with Opiate Dependence and Drug Dependence, run by Merck Sharp & Dohme LLC.
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 8 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 May 2011). 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?
Responders at Day 3 (time frame: 3 days). 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 NCT00604188, 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 2 Jul 2017.