Chronic PainNCT02737826
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
A study testing Buprenorphine Initiation - Phase I, Gabapentin + Buprenorphine - Phase II and Buprenorphine taper - Phase II in people with Chronic Pain and Opioid Pain Medication, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Chronic opioid therapy for pain can be associated with significant risks, and a significant number of patients maintained on chronic opioids have continued pain and/or poor functioning. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Opioid Pain Medication
- What is being tested?
- Buprenorphine Initiation - Phase I, Gabapentin + Buprenorphine - Phase II and Buprenorphine taper - Phase II
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 13 Jan 2021
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 70 years of age
- Ability to speak and read in English
- Currently taking chronic opioid therapy for pain for at least 6 months
- On opioid dose of >60mg and <200mg oral morphine equivalents/day
- Voluntarily seeking opioid discontinuation
- Willing to attempt buprenorphine-assisted opioid discontinuation
- Willing to be randomized to gabapentin or placebo
- Have current physician who is actively prescribing opioids and who will be notified by the research team of the patient's entry into the study.
Who cannot join
- Previous intolerance or allergy to buprenorphine or gabapentin
- Diagnostic \& Statistical Manual -V criteria for substance use disorder currently or in the past (other than nicotine)
- Unstable medical or psychiatric condition that would preclude safe or meaningful participation (e.g. traumatic brain injury; severe mental illness; severe cardiac, renal, pulmonary, or liver disease)
- Current use of illicit drugs
- Maintenance on fentanyl or methadone
- Current treatment with gabapentin
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29424
About this study
Chronic opioid therapy for pain can be associated with significant risks, and a significant number of patients maintained on chronic opioids have continued pain and/or poor functioning. When patients need to or want to come off their opioid pain medications, there is little to guide physicians as to how to best help them do so, and it is not known how patients do after coming off opioid medications. The goals of this study are (1) to evaluate two medications in assisting patients in coming off their opioid pain medications and (2) determining outcomes after discontinuing opioids.
- Conditions
- Chronic Pain, Opioid Pain Medication
- Being tested
- Buprenorphine Initiation - Phase I, Gabapentin + Buprenorphine - Phase II, Placebo + Buprenorphine - Phase II, Buprenorphine taper - Phase II
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine Initiation - Phase IDrug
In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an 8 hour induction window.
Gabapentin + Buprenorphine - Phase IIDrug
Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
Placebo + Buprenorphine - Phase IIDrug
Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
Buprenorphine taper - Phase IIDrug
After a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Phase - Buprenorphine Initiation | Experimental | In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an up to 8 hour induction window. "Buprenorphine tolerability" will be defined as pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper. Receives: Drug: Buprenorphine Initiation - Phase I |
| Phase II - Gabapentin + Buprenorphine | Active comparator | Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg oral gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated. Receives: Drug: Gabapentin + Buprenorphine - Phase II |
| Phase II - Placebo + Buprenorphine | Placebo comparator | Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg oral placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated. Receives: Drug: Placebo + Buprenorphine - Phase II |
| Phase II - Buprenorphine taper | Experimental | After a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms. Receives: Drug: Buprenorphine taper - Phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Tolerate Buprenorphine Initiation
For Phase I, the primary outcome measure is the percentage of patients who tolerate buprenorphine initiation within an 8-hour initiation period, as evidenced by a total score of 3 points when summing the following measures (1) moderate-good level of pain control (same or improved rating on a 0-10 visual analogue scale for pain) = 1 point, (2) mild to no withdrawal symptoms (≤10 on the Subjective Opioid Withdrawal Scale) = 1 point, and (3) willingness to continue to the stabilization and tapering phase of the study; "yes" = 1 point.
Measured: 8 hours post dose
Number of Participants Who Achieve Opioid Cessation
For Phase II, the primary outcome measure will be number of participants opioid who achieve cessation 8 weeks after stabilization at Week 10, evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.
Measured: 8 weeks after stabilization at Week 10
Secondary outcomes (11)
Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month
Opioid cessation post taper: 1 month with opioid cessation measured through self-report, prescription drug monitoring data, and confirmatory UDS for a full panel of opioids.
Measured: 1 month post-taper
Pain Self-report: Pain Catastrophizing Scale - Baseline
The Self Reporting Pain Catastrophizing scale consists of 13 items scored from 0 to 4. The total possible score is 52. A higher score indicates more catastrophizing thoughts are present. A lower score indicates less catastrophizing thoughts.
Measured: Baseline
Pain Laboratory Testing: Mechanical - Baseline
Mechanical (Pressure) Pain Threshold Assessment (PPTh): A digital anesthesiometer (IITC Life Sciences ElectroVonFrey) will be used to assess mechanical pain perception. Pain threshold to static mechanical stimuli will be determined by applying the rigid monofilament to the dorsum of each subject's right hand with increasing pressure (10 grams per second) until the participant indicates verbally that the pain threshold has been reached.
Measured: Baseline
Mean Score of Current Opioid Measure (COMM)
COMM is a 17 item questionnaire that is used to examine concurrent misuse. The score range is from 0-28. A lower score represents participant showing less aberrant behaviors associates with misuse of option medications, and a higher score represents more aberrant behaviors associated with opioid medical misuse.
Measured: Baseline
Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH
The Mean score of Physical Function on PROMIS short form. The global physical health score is a sum of responses to 4 questions. The range is from 4-20. A lower score represents lower physical function.
The following questions will be asked: In general, how would you rate your physical health? (range is 1-5; 1 represents poor rating in health, 5 represents excellent rating of physical health) To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? (range is 1-5; 1 represents score of not at all, 5 represents score of completely) How would you rate your fatigue on average? (range is 1-5; 1 represents very severe fatigue, and 5 represents no fatigue) How would you rate your pain on average (range is 0-10; 0 represents no pain, 10 represents worst pain imaginable). The pain score is then recoded: 0, no pain = 5; 1, 2, or 3 = 4; 4, 5, or 6 =3; 7, 8, 9 =2;10 =1
Measured: baseline
Mean Score Pittsburgh Sleep Quality Index
The PSQI is a 19 item self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components (time gone to bed, how long it takes to go to sleep, wake up time, hours slept, issues sleeping, total hours slept etc.) that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, A lower scale is indicative of better sleep quality and higher score represents poor sleep quality.
Measured: baseline
Mean Score of Subjective Opioid Withdrawal Scale (SOWS)
The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64.
Measured: baseline
Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months
Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.
Measured: Post-taper - 3 months
Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months
Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.
Measured: Post-taper - 6 months
Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months
Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.
Measured: Post-taper - 12 months
Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline
DNIC will be measured as the percent change in PPTh during the cold pressor tasks relative to baseline. A percent increase represents normal functioning of pain inhibitory processes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion9 Dec 2019
- Study completion13 Jan 2021
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.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737826
- Sponsor's protocol ID
- Pro00046473
- Status last verified
- Nov 2022
- First submitted
- 14 Mar 2016
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
- ClinicalTrials.gov ID
- NCT02737826
- Acronym / sponsor ID
- Pro00046473
- Conditions
- Chronic Pain, Opioid Pain Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 13 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic opioid therapy for pain can be associated with significant risks, and a significant number of patients maintained on chronic opioids have continued pain and/or poor functioning. When patients need to or want to come off their opioid pain medications, there is little to guide physicians as to how to best help them do so, and it is not known how patients do after coming off opioid medications. The goals of this study are (1) to evaluate two medications in assisting patients in coming off their opioid pain medications and (2) determining outcomes after discontinuing opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase - Buprenorphine Initiation | Experimental | Drug: Buprenorphine Initiation - Phase IIn Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an up to 8 hour induction window. "Buprenorphine tolerability" will be defined as pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper. |
| Phase II - Gabapentin + Buprenorphine | Active comparator | Drug: Gabapentin + Buprenorphine - Phase IISubjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg oral gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated. |
| Phase II - Placebo + Buprenorphine | Placebo comparator | Drug: Placebo + Buprenorphine - Phase IISubjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg oral placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated. |
| Phase II - Buprenorphine taper | Experimental | Drug: Buprenorphine taper - Phase IIAfter a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 - 70 years of age
- Ability to speak and read in English
- Currently taking chronic opioid therapy for pain for at least 6 months
- On opioid dose of >60mg and <200mg oral morphine equivalents/day
- Voluntarily seeking opioid discontinuation
Key exclusion criteria (6 listed)
- Previous intolerance or allergy to buprenorphine or gabapentin
- Diagnostic \& Statistical Manual -V criteria for substance use disorder currently or in the past (other than nicotine)
- Unstable medical or psychiatric condition that would preclude safe or meaningful participation (e.g. traumatic brain injury; severe mental illness; severe cardiac, renal, pulmonary, or liver disease)
- Current use of illicit drugs
- Maintenance on fentanyl or methadone
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 Initiation - Phase IIn Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an 8 hour induction window. | Drug | Phase - Buprenorphine Initiation |
| Gabapentin + Buprenorphine - Phase IISubjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated. | Drug | Phase II - Gabapentin + Buprenorphine |
| Placebo + Buprenorphine - Phase IISubjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated. | Drug | Phase II - Placebo + Buprenorphine |
| Buprenorphine taper - Phase IIAfter a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms. | Drug | Phase II - Buprenorphine taper |
Primary outcome
Percentage of Patients Who Tolerate Buprenorphine Initiation
Time frame: 8 hours post dose
For Phase I, the primary outcome measure is the percentage of patients who tolerate buprenorphine initiation within an 8-hour initiation period, as evidenced by a total score of 3 points when summing the following measures (1) moderate-good level of pain control (same or improved rating on a 0-10 visual analogue scale for pain) = 1 point, (2) mild to no withdrawal symptoms (≤10 on the Subjective Opioid Withdrawal Scale) = 1 point, and (3) willingness to continue to the stabilization and tapering phase of the study; "yes" = 1 point.
Number of Participants Who Achieve Opioid Cessation
Time frame: 8 weeks after stabilization at Week 10
For Phase II, the primary outcome measure will be number of participants opioid who achieve cessation 8 weeks after stabilization at Week 10, evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.
11 secondary outcomes
Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month
Time frame: 1 month post-taper
Pain Self-report: Pain Catastrophizing Scale - Baseline
Time frame: Baseline
Pain Laboratory Testing: Mechanical - Baseline
Time frame: Baseline
Mean Score of Current Opioid Measure (COMM)
Time frame: Baseline
Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH
Time frame: baseline
Mean Score Pittsburgh Sleep Quality Index
Time frame: baseline
Mean Score of Subjective Opioid Withdrawal Scale (SOWS)
Time frame: baseline
Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months
Time frame: Post-taper - 3 months
Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months
Time frame: Post-taper - 6 months
Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months
Time frame: Post-taper - 12 months
Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buprenorphine Initiation - Phase I, Gabapentin + Buprenorphine - Phase II and Buprenorphine taper - Phase II in people with Chronic Pain and Opioid Pain Medication, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2021). 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?
Percentage of Patients Who Tolerate Buprenorphine Initiation (time frame: 8 hours post dose). 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?
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 1 Dec 2022.