Acute Post-surgical PainPhase 3NCT03108482
Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.
A Phase 3 study testing Co-crystal E-58425 (Tramadol/Celecoxib), Tramadol (Ultram®) and Celecoxib (Celebrex®) in people with Acute Post-surgical Pain, run by Esteve Pharmaceuticals, S.A. at 5 sites in United States.
Trial summary
This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior effect compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Post-surgical Pain
- What is being tested?
- Co-crystal E-58425 (Tramadol/Celecoxib), Tramadol (Ultram®) and Celecoxib (Celebrex®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 637 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Mar 2017to 28 Nov 2017
- Phase
- Phase 3
- 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
- Subject must have signed consent before study entry.
- Subject must be at least 18 years old, scheduled to undergo primary unilateral first metatarsal osteotomy with internal fixation with no additional collateral procedure.
- Male and female subjects are eligible. If female, subject must be either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following effective methods of birth control:
- Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives.
- Total abstinence from sexual intercourse since the last menses before study medication administration.
- Intrauterine device
Show all 13Show fewer
- Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
- Women must use effective methods of birth control from 6 weeks before administration of study medication until 4 weeks after the last administration.
- If female and of childbearing potential, subject must be non-lactating and non pregnant (has negative serum pregnancy test results at Screening and negative urine test on the day of surgery prior to surgery).
- Subject must have a body weight of 45 kg or more and a body mass index (BMI) of 40 kg/m2 or less.
- Subject must have a qualifying pain score of ≥5 and <9 on the 0-10 NPRS at rest as a result of turning off the popliteal sciatic block for bunionectomy to be eligible for randomization.
- Subject must be in good physical health in the investigator's judgment.
- Subject must be sufficiently alert to understand and communicate intelligibly with the study observer.
Who cannot join
- Subject's Baseline pain is <5 or >9 on a 0-10 NPRS.
- Subject received any analgesic medication other than short-acting pre-operative or intra-operative anesthetic agents before the end of bunionectomy surgical procedure. Subjects who received any analgesic medication immediately after the bunionectomy surgical procedure was completed and before study medication is administered will also be excluded, with the exception of ketorolac 30 mg intravenously supplemental analgesia during the continuous infusion period and up until 1:00 A.M.
- Subject has a history of seizures or alcohol abuse (eg, drinks >4 units of alcohol per day, a unit being equal to 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years, has a history of prescription/illicit drug abuse within 6 months before dosing with study medication, or has positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- Subject has a history of or positive test results for human immunodeficiency virus or hepatitis B or C.
- Subject has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding successfully treated squamous or basal cell carcinoma of the skin).
- Subject is currently receiving anticoagulants (eg, heparin or warfarin) or antiplatelets (except aspirin ≤325 mg/day).
Show all 25Show fewer
- Subject has received a course of systemic (either oral or parenteral) or intra-articular corticosteroids within 3 months before Screening (inhaled nasal steroids and topical corticosteroids are allowed).
- Subject has any ongoing condition, other than one associated with the current primary, unilateral, first metatarsal bunionectomy, that, in the investigator's opinion, could generate levels of pain sufficient to confound assessments of post-operative pain (eg, severe osteoarthritis of the target joint or extremity, fibromyalgia, rheumatoid arthritis, moderate to severe headache, diabetic foot pain or neuropathy).
- Subject has been receiving or has received chronic (defined as daily use for >2 weeks) opioid (oral codeine, dextromoramide, dihydrocodeine, oxycodone, or morphine-like anti-tussive) therapy defined as >15 morphine equivalents units per day for more than 3 out of 7 days per week over a 1-month period within 12 months of surgery, or has been treated chronically with opioid analgesic (buprenorphine, nalbuphine, or pentazocine) or NSAIDs within 30 days before Screening.
- Subject received a long-acting Non-Steroidal Anti-Inflammatory Drug (NSAID) within 4 days before initiation of study medication (except aspirin ≤325 mg/day), or a short-acting NSAID within 1 day.
- Subject is under long-term treatment with opioid agonist-antagonists.
- Subject has used drugs with enzyme-inducing properties, such as rifampicin and St. John's Wort, or any drug known to be a strong inhibitor or inducer of CYP3A4, CYP2C9, or CYP2D6 within 3 weeks before surgery.
- Subject is pregnant or lactating.
- Subject had any complication during primary bunionectomy surgery.
- Subject has received monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce the seizure threshold within 4 weeks of study entry.
- Subject has a history or evidence of a clinically significant (in the investigator's opinion) gastrointestinal (GI) event within 6 months before Screening or has any history of peptic or gastric ulcers or GI bleeding.
- Subject has clinically significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥3 times the upper limit of normal for any liver function test, including aspartate aminotransferase, alanine aminotransferase, bilirubin, and lactate dehydrogenase, or creatinine ≥1.5 times the upper limit of normal). Laboratory tests may be repeated once at Screening to rule out laboratory error.
- Subject has any clinically significant laboratory or 12-lead electrocardiogram (ECG) finding at Screening that, in the opinion of the investigator, contraindicates study participation (eg, QTc >450 msec [male] or >470 msec [female]).
- Subject has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any NSAIDs; history of NSAID induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully) or to the ingredients of the study medication, or any other drugs used in the study, including anesthetics and antibiotics that may be required on the day of surgery.
- Subject has received anti-depressive medication with serotonin-norepinephrine reuptake inhibitors (SNRIs; milnacipran, duloxetine, venlafaxine), diet pills (including fenfluramine and phentermine) or methylphenidate (Ritalin®), or other similar medications for attention deficit hyperactivity disorder (ADHD) within 4 weeks of study entry. Subjects receiving selective serotonin reuptake inhibitors (SSRIs) may be included provided they have been on a stable dose for 60 days prior to study participation and plan to remain on that dose throughout the study.
- Subject is at risk in terms of precautions, warnings, and contraindications in the package insert for Ultram® (tramadol hydrochloride) or Celebrex® (celecoxib).
- Subject has a known coagulation disorder.
- Subject has history of or current medical, surgical, post-surgical, or psychiatric condition that would confound interpretation of safety, tolerability, or efficacy, (eg, uncontrolled diabetes mellitus, uncontrolled hypertension, hemodynamic instability, or respiratory insufficiency, cancer or palliative care).
- Subject received an experimental drug or used an experimental medical device within 30 days prior to Screening or has previously participated in this trial.
- Subject is unable to comply with the requirements of the study or, in the investigator's opinion, should not participate in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Optimal Research, LLC
Austin, Texas, 78705
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122
Arizona Research Center
Phoenix, Arizona, 85023
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Randomized, Double-blind, Active- (Tramadol and Celecoxib) and Placebo-controlled, Parallel Groups, Phase 3 Clinical Trial to Establish the Efficacy of Co-crystal E-58425 for the Management of Moderate to Severe Post-surgical Pain After Bunionectomy.
This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior effect compared to tramadol and to celecoxib for the management of moderate to severe acute post-operative pain for 48 hours after bunionectomy.
- Conditions
- Acute Post-surgical Pain
- Being tested
- Co-crystal E-58425 (Tramadol/Celecoxib), Tramadol (Ultram®), Celecoxib (Celebrex®), Placebo
- Keywords
- Acute Pain, Post-surgical Pain, Bunionectomy, Co-crystal, Tramadol, Celecoxib
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-crystal E-58425 (Tramadol/Celecoxib)Drug
Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours.
Tramadol (Ultram®)Drug
Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.
Celecoxib (Celebrex®)Drug
Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours.
PlaceboDrug
Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Co-crystal E-58425 (Tramadol/Celecoxib) | Experimental | Co-crystal E-58425 (Tramadol/Celecoxib): Two tablets of 100 mg every 12 hours. The total daily dose will be 400 mg of Co-crystal E-58425. Receives: Drug: Co-crystal E-58425 (Tramadol/Celecoxib) |
| Tramadol (Ultram®) | Active comparator | Tramadol: One tablet of 50 mg every 6 hours. The total daily dose will be 200 mg of tramadol. Receives: Drug: Tramadol (Ultram®) |
| Celecoxib (Celebrex®) | Active comparator | Celecoxib: One capsule of 100 mg every 12 hours. The total daily dose will be 200 mg of celecoxib. Receives: Drug: Celecoxib (Celebrex®) |
| Placebo | Placebo comparator | Placebo: One or two tablets of 100 mg every 6 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Differences (SPID)
The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Pain Rating Scale (NPRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain". The primary analysis endpoint was the Sum of Pain Intensity Differences (SPID) from 0 to 48 hours. Pain Intensity Differences (PID) was the difference between current PI at assessment minus baseline PI (prior to the first dose). Baseline PI ranged from 5 to 9. SPID was calculated as a time-weighted Sum of PID scores over 48 hours. Negative differences correspond to an amelioration of pain, while positive differences correspond to recrudescence of pain. The total scale ranged from -480 (best) to +480 (worst). A higher negative value of SPID indicates greater pain relief.
Measured: Assessments was recorded from time 0 to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start14 Mar 2017
- Primary completion9 Nov 2017
- Study completion28 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Post-surgical PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esteve Pharmaceuticals, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Jesus Cebrecos, MD, MBA, Study director, Esteve Pharmaceuticals, S.A.Michael Kuss, Study chair, Premier ResearchIra J Gottlieb, DPM, Principal investigator, Chesapeake Research Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108482
- Sponsor's protocol ID
- ESTEVE-SUSA-301
- Status last verified
- Jan 2019
- First submitted
- 30 Mar 2017
- Last updated
- 24 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morte A, Sust M, Vaque A, Cebrecos J, Gimenez-Arnau JM. Adverse Reactions Following First-Dose Administration of Co-Crystal of Tramadol-Celecoxib Versus Tramadol Alone for Moderate-To-Severe Acute Pain. Pain Ther. 2025 Jun;14(3):1147-1154. doi: 10.1007/s40122-025-00730-w. Epub 2025 May 2.
PubMed 40314885Viscusi ER, Langford R, Morte A, Vaque A, Cebrecos J, Sust M, Gimenez-Arnau JM, de Leon-Casasola O. Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials. Pain Ther. 2024 Dec;13(6):1617-1631. doi: 10.1007/s40122-024-00655-w. Epub 2024 Sep 24.
PubMed 39316284
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active- (Tramadol and Celecoxib) and Placebo-controlled, Parallel Groups, Phase 3 Clinical Trial to Establish the Efficacy of Co-crystal E-58425 for the Management of Moderate to Severe Post-surgical Pain After Bunionectomy.
- ClinicalTrials.gov ID
- NCT03108482
- Acronym / sponsor ID
- ESTEVE-SUSA-301
- Conditions
- Acute Post-surgical Pain
- Keywords
- Acute Pain, Post-surgical Pain, Bunionectomy, Co-crystal, Tramadol, Celecoxib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Esteve Pharmaceuticals, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Posted 9 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior effect compared to tramadol and to celecoxib for the management of moderate to severe acute post-operative pain for 48 hours after bunionectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Co-crystal E-58425 (Tramadol/Celecoxib) | Experimental | Drug: Co-crystal E-58425 (Tramadol/Celecoxib)Co-crystal E-58425 (Tramadol/Celecoxib): Two tablets of 100 mg every 12 hours. The total daily dose will be 400 mg of Co-crystal E-58425. |
| Tramadol (Ultram®) | Active comparator | Drug: Tramadol (Ultram®)Tramadol: One tablet of 50 mg every 6 hours. The total daily dose will be 200 mg of tramadol. |
| Celecoxib (Celebrex®) | Active comparator | Drug: Celecoxib (Celebrex®)Celecoxib: One capsule of 100 mg every 12 hours. The total daily dose will be 200 mg of celecoxib. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: One or two tablets of 100 mg every 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject must have signed consent before study entry.
- Subject must be at least 18 years old, scheduled to undergo primary unilateral first metatarsal osteotomy with internal fixation with no additional collateral procedure.
- Male and female subjects are eligible. If female, subject must be either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following effective methods of birth control:
- Women must use effective methods of birth control from 6 weeks before administration of study medication until 4 weeks after the last administration.
- If female and of childbearing potential, subject must be non-lactating and non pregnant (has negative serum pregnancy test results at Screening and negative urine test on the day of surgery prior to surgery).
Key exclusion criteria (25 listed)
- Subject's Baseline pain is <5 or >9 on a 0-10 NPRS.
- Subject received any analgesic medication other than short-acting pre-operative or intra-operative anesthetic agents before the end of bunionectomy surgical procedure. Subjects who received any analgesic medication immediately after the bunionectomy surgical procedure was completed and before study medication is administered will also be excluded, with the exception of ketorolac 30 mg intravenously supplemental analgesia during the continuous infusion period and up until 1:00 A.M.
- Subject has a history of seizures or alcohol abuse (eg, drinks >4 units of alcohol per day, a unit being equal to 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years, has a history of prescription/illicit drug abuse within 6 months before dosing with study medication, or has positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- Subject has a history of or positive test results for human immunodeficiency virus or hepatitis B or C.
- Subject has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding successfully treated squamous or basal cell carcinoma of the skin).
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 |
|---|---|---|
| Co-crystal E-58425 (Tramadol/Celecoxib)Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours. | Drug | Co-crystal E-58425 (Tramadol/Celecoxib) |
| Tramadol (Ultram®)Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours. | Drug | Tramadol (Ultram®) |
| Celecoxib (Celebrex®)Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours. | Drug | Celecoxib (Celebrex®) |
| PlaceboPlacebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours. | Drug | Placebo |
Primary outcome
Sum of Pain Intensity Differences (SPID)
Time frame: Assessments was recorded from time 0 to 48 hours.
The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Pain Rating Scale (NPRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain". The primary analysis endpoint was the Sum of Pain Intensity Differences (SPID) from 0 to 48 hours. Pain Intensity Differences (PID) was the difference between current PI at assessment minus baseline PI (prior to the first dose). Baseline PI ranged from 5 to 9. SPID was calculated as a time-weighted Sum of PID scores over 48 hours. Negative differences correspond to an amelioration of pain, while positive differences correspond to recrudescence of pain. The total scale ranged from -480 (best) to +480 (worst). A higher negative value of SPID indicates greater pain relief.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40314885Morte A, Sust M, Vaque A, Cebrecos J, Gimenez-Arnau JM. Adverse Reactions Following First-Dose Administration of Co-Crystal of Tramadol-Celecoxib Versus Tramadol Alone for Moderate-To-Severe Acute Pain. Pain Ther. 2025 Jun;14(3):1147-1154. doi: 10.1007/s40122-025-00730-w. Epub 2025 May 2.
- Derived from this study: PubMed 39316284Viscusi ER, Langford R, Morte A, Vaque A, Cebrecos J, Sust M, Gimenez-Arnau JM, de Leon-Casasola O. Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials. Pain Ther. 2024 Dec;13(6):1617-1631. doi: 10.1007/s40122-024-00655-w. Epub 2024 Sep 24.
- 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.
Jesus Cebrecos, MD, MBA study director
Esteve Pharmaceuticals, S.A.
Michael Kuss study chair
Premier Research
Ira J Gottlieb, DPM principal investigator
Chesapeake Research Group, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Co-crystal E-58425 (Tramadol/Celecoxib), Tramadol (Ultram®) and Celecoxib (Celebrex®) in people with Acute Post-surgical Pain, run by Esteve Pharmaceuticals, S.A. at 5 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 13 inclusion and 25 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 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 Jan 2019). 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?
Sum of Pain Intensity Differences (SPID) (time frame: Assessments was recorded from time 0 to 48 hours.). 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 NCT03108482, which also lists 2 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 24 Jan 2019.