Osteo Arthritis KneePhase 2NCT03028870
A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee
A Phase 2 study testing V120083 and Naproxen in people with Osteo Arthritis Knee, run by Purdue Pharma LP at 30 sites in United States.
Trial summary
The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- V120083 and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 30 sitesUnited States
- Study dates
- 14 Mar 2017to 21 Nov 2017
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic OA pain of the knee (lasting several hours daily) as their predominant pain condition for at least 6 months prior to screening
- Diagnostic criteria for primary pain condition (American College of Rheumatology [ACR] clinical and radiographic criteria):
- At least 1 of the following in addition to knee pain: age > 50, morning stiffness < 30 minutes, crepitus on active motion, and
- Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit as determined by a local radiologist or rheumatologist. If a radiograph is not available, one must be taken and the diagnostic criteria must be confirmed before randomization.
- Subjects whose OA pain of the index knee is not adequately treated prior to the screening visit:
- Subjects must have a self-reported average pain intensity rating of moderate or severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7 days prior to the screening visit
- The subjects must have "average pain over the last 24 hours" scores ≥ 4 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry
- Subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for OA pain for the duration of the study, with the exception of study-specific rescue medication.
Who cannot join
- Subjects with radiographic evidence of OA with K-L grade 0,1 or 4
- Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area
- Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
- Subjects with a history of a prior joint replacement of the index knee
- Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study
- Subjects with a history of significant trauma to a knee, hip or shoulder within the previous year
- Subjects who have significant pain, other than or more than knee pain, including significant hip, back pain, that may confound the analgesic efficacy assessments of this study.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
FutureSearch Trials of Neurology
Austin, Texas, 78731
Hassman Research Institute
Berlin, New Jersey, 08009
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, 45439
Medication Management, LLC
Greensboro, North Carolina, 27408
Mountain View Clinical Research, Inc.
Greer, South Carolina, 29651
Drug Trials America
Hartsdale, New York, 10530
Future Care Solution, LLC
Miami, Florida, 33165
New Horizon Research Center
Miami, Florida, 33175
Research Institute of the Carolinas of Piedmont Healthcare, PA
Mooresville, North Carolina, 28117
Burke Primary Care
Morganton, North Carolina, 28655
Providence Clinical Research
North Hollywood, California, 91606
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Omega Research Consultants, LLC
Orlando, Florida, 32810
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Diagnostics Research Group
San Antonio, Texas, 78229
Artemis Institute for Clinical Research
San Diego, California, 92103
Artemis Institute for Clinical Research
San Marcos, California, 92078
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
St. Louis Clinical Trials, LC
St Louis, Missouri, 63141
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Montefiore Medical Center
The Bronx, New York, 10467
Terence T. Hart, MD
Tuscumbia, Alabama, 35674
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383
Omega Medical Research
Warwick, Rhode Island, 02886
Palm Beach Research Center
West Palm Beach, Florida, 33409
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
About this study
Official title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
- Conditions
- Osteo Arthritis Knee
- Being tested
- V120083, Naproxen, Placebo
- Keywords
- Osteoarthritis, Pain, Osteoarthritis Knee
- Medical subject headings
- Osteoarthritis, Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V120083Drug
Capsules
NaproxenDrug
Capsules
PlaceboDrug
Capsules to match V120083 and/or naproxen
| Study group | Role | What they receive |
|---|---|---|
| V120083 30 mg | Experimental | V120083 30-mg capsules taken orally twice daily Receives: Drug: V120083; Drug: Placebo |
| V120083 60 mg | Experimental | V120083 60-mg (2 x 30 mg) capsules taken orally twice daily Receives: Drug: V120083; Drug: Placebo |
| Naproxen | Active comparator | Naproxen 500-mg capsules taken orally twice daily Receives: Drug: Naproxen; Drug: Placebo |
| Placebo | Placebo comparator | Capsules to match V120083 and/or naproxen taken orally twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Measured: Week 4
Secondary outcomes (17)
Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Measured: Weeks 1, 2 and 4
Average Daily "Pain Right Now" Score Collected by e-Diary
Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Measured: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.
Measured: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.
Measured: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.
Measured: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.
Measured: 4 Weeks
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.
Measured: 4 Weeks
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.
Measured: 4 Weeks
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.
Measured: 4 Weeks
Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4
A subject's response to treatment was defined as the percentage reduction from the baseline "average pain over the last 24 hours" score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having > 0 % reduction; non-responders were defined as having ≤ 0% reduction.
Measured: Week 4
Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Measured: 4 Weeks
Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Measured: 4 Weeks
European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
Measured: 4 Weeks
Patient Global Impression of Change (PGIC)
The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding "very much improved" and "much improved" was summarized by treatment group.
Measured: 4 Weeks
Supplemental Analgesic Medication Use
The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.
Measured: Up to 28 days
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.
Measured: Baseline up to 4 Weeks
Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start14 Mar 2017
- Primary completion10 Nov 2017
- Study completion21 Nov 2017
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 Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028870
- Sponsor's protocol ID
- VAN2001
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2017
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03028870
- Acronym / sponsor ID
- VAN2001
- Conditions
- Osteo Arthritis Knee
- Keywords
- Osteoarthritis, Pain, Osteoarthritis Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Collaborators
- Shionogi
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 15 Nov 2018
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 evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| V120083 30 mg | Experimental | Drug: V120083, Drug: PlaceboV120083 30-mg capsules taken orally twice daily |
| V120083 60 mg | Experimental | Drug: V120083, Drug: PlaceboV120083 60-mg (2 x 30 mg) capsules taken orally twice daily |
| Naproxen | Active comparator | Drug: Naproxen, Drug: PlaceboNaproxen 500-mg capsules taken orally twice daily |
| Placebo | Placebo comparator | Drug: PlaceboCapsules to match V120083 and/or naproxen taken orally twice daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic OA pain of the knee (lasting several hours daily) as their predominant pain condition for at least 6 months prior to screening
- Diagnostic criteria for primary pain condition (American College of Rheumatology [ACR] clinical and radiographic criteria):
- Subjects whose OA pain of the index knee is not adequately treated prior to the screening visit:
- The subjects must have "average pain over the last 24 hours" scores ≥ 4 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry
- Subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for OA pain for the duration of the study, with the exception of study-specific rescue medication.
Key exclusion criteria (7 listed)
- Subjects with radiographic evidence of OA with K-L grade 0,1 or 4
- Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area
- Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
- Subjects with a history of a prior joint replacement of the index knee
- Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the 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 |
|---|---|---|
| V120083Capsules | Drug | V120083 30 mg, V120083 60 mg |
| NaproxenCapsules | Drug | Naproxen |
| PlaceboCapsules to match V120083 and/or naproxen | Drug | Naproxen, Placebo, V120083 30 mg, V120083 60 mg |
Primary outcome
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
Time frame: Week 4
At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
17 secondary outcomes
Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
Time frame: Weeks 1, 2 and 4
Average Daily "Pain Right Now" Score Collected by e-Diary
Time frame: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
Time frame: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
Time frame: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
Time frame: 4 Weeks
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
Time frame: 4 Weeks
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
Time frame: 4 Weeks
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
Time frame: 4 Weeks
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
Time frame: 4 Weeks
Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4
Time frame: Week 4
Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
Time frame: 4 Weeks
Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
Time frame: 4 Weeks
European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
Time frame: 4 Weeks
Patient Global Impression of Change (PGIC)
Time frame: 4 Weeks
Supplemental Analgesic Medication Use
Time frame: Up to 28 days
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
Time frame: Baseline up to 4 Weeks
Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V120083 and Naproxen in people with Osteo Arthritis Knee, run by Purdue Pharma LP at 30 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 8 inclusion and 7 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2018). 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?
Daily "Average Pain Over the Last 24 Hours" Score at Week 4 (time frame: Week 4). 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 12 Feb 2019.