PainPhase 4NCT06165432
Pre Injection Use of Cryoanesthesia Versus Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections
A Phase 4 study testing Topical Benzocaine and Topical ice in people with Pain, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
The goal of this interventional study is to assess the effectiveness of pre-injection use of topical ice application in decreasing pain perception when administering greater palatine nerve block injections as compared to that of topical 20 % benzocaine anesthetic gel using Visual Analogue Scale (VAS) for subjective… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Topical Benzocaine and Topical ice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 19 Mar 2021to 5 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinically healthy patients ASA I and ASA II with intact palatal mucosa on both sides
- Procedures that needs administration of greater palatine nerve block
Who cannot join
- Hypersensitivity to local anesthetic agent
- Patient who are physically and mentally sub normal
- Presence of palatal mucosal lesions
- Patients on long term neuromodulators for chronic pain
- Patient not consenting to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Pre Injection Use of Cryoanesthesia as Compared to Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections
The goal of this interventional study is to assess the effectiveness of pre-injection use of topical ice application in decreasing pain perception when administering greater palatine nerve block injections as compared to that of topical 20 % benzocaine anesthetic gel using Visual Analogue Scale (VAS) for subjective pain assessment and Sound, Eye, Motor (SEM) scale for objective pain assessment in adult patients.
The main question it aims to answer are:
Read more
- Does topical cooling reduce pain as effectively as topical benzocaine during greater palatine nerve block injections?
- Is there any adverse reactions during and after application of topical ice and 20 % benzocaine gel?
- Is there any difference in patient acceptability to the use of either methods during the administration of greater palatine nerve block.
A split mouth design was used where an anesthetic injection was administered in the left and right posterior palatal area. The same operator administered the injections so as to standardize the flow rate and delivery style. The method of intervention i.e topical ice or topical 20% benzocaine anesthetic gel was randomly allocated to the patient by lottery method. The participants received two palatal injections with an interval of two weeks between the appointments. The subjective pain response of the patients during greater palatine nerve block injection with pre-injection use of topical ice and topical anesthetic gel (20% benzocaine) was recorded using VAS scale. The objective pain response of the patients were recorded by a blinded single observer using SEM scale on the same day of the appointment.
Technique of application of topical ice: A new pack of sterile cotton swabstick that was injected with 0.5ml commercially available bottled water and then freezed the day before the appointment. At the time of intervention the injection site was dried with gauge piece and the frozen cotton swab stick was held by its wooden part and the frozen cotton end was placed on the proposed anesthetic site (palatal mucosa just anterior to the greater palatine foramen) for 1 minute. With the frozen cotton swabstick in place, an injection of 0.5 mL of 2 percent Lidocaine with 1:200,000 epinephrine was administered into the injection site via a 27-gauge short needle.
Technique of application of topical anesthetic gel: After the oral mucosa was dried with a gauze piece, application of 0.2 mL Benzocaine 20% gel was done with a sterile swab stick on the proposed anesthetic site (palatal mucosa just anterior to the greater palatine foramen) for a period of two minutes as shown in figure. With the cotton swabstick in place an injection of 0.5 mL of 2 percent Lidocaine with 1:200,000 epinephrine was administered into the injection site via a 27-gauge short needle.
- Conditions
- Pain
- Being tested
- Topical Benzocaine, Topical ice
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical BenzocaineDrug
Benzocaine topical anesthetic gel will be used a pre-injection anesthetic on one half of the palate before giving greater palatine nerve block
Topical iceOther
For the other half of the palate topical ice would be used before greater palatine nerve block
| Study group | Role | What they receive |
|---|---|---|
| Drug Arm :Topical benzocaine | Active comparator | since its a split mouth study one half of the hard palate will receive topical benzocaine i.e Group A Receives: Drug: Topical Benzocaine |
| Topical ice | Active comparator | Other half of the palate will receive topical ice i.e Group B Receives: Other: Topical ice |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective pain perception during greater palatine nerve block injection
measured using Visual analogue Scale (VAS) - The Visual Analogue Scale (VAS) consisting of a 100 mm straight line with the endpoints marked to denote extreme limits on the left as 'no pain at all' and on the right as 'pain as bad as it could be' was used to record the pain score . The patient was asked to mark their pain level on the line between the two endpoints after receiving the palatal injection. The distance between 'no pain at all' and the mark defined the subject's pain which was measured in millimeters.
Measured: Immediatley after the injection
objective pain perception during greater palatine nerve block injection
measured using Sound, Eye and Motor (SEM) scale -The SEM scale was used in the assessment of the relationship between pain and the reactions which the sensation of pain generates in the patient's eyes, bodily movements and verbal expressions of discomfort
Measured: During the injection procedure
Secondary outcomes (2)
Adverse effects
Immediate adverse side effects like burning/stinging sensation, local hypersensitivity reaction (urticaria, erythema, itching) and immediate systemic effects (dizziness, drowsiness, palpitations) were assessed; marked as 0: absent and 1: present.
Measured: upto 30 minutes after the injection
Acceptability regarding the use of either topical ice or topical benzocaine
The overall patient perception regarding the use of topical ice and topical benzocaine as a preanesthetic agent was assessed using a 5 point Likert scale containing 5 response options that consisted of two extreme sides and a neutral option.
The five response options were: 1.Very bad, 2 Bad, 3. satisfactory 4. Good and 5. Very Good
Measured: 5 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start19 Mar 2021
- Primary completion20 Sep 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross sectional comparative split mouth study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddhartha Rai, B.P. Koirala Institute of Health Sciences
- Investigators
- Mehul Jaisani, MDS, Study chair, B.P. Koirala Insititute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165432
- Sponsor's protocol ID
- 556/077/078
- Status last verified
- Dec 2023
- First submitted
- 5 Sep 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
PubMed 31842771Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
PubMed 26957683Kumar M, Chawla R, Goyal M. Topical anesthesia. J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):450-6. doi: 10.4103/0970-9185.169049.
PubMed 26702198Meechan JG. Intra-oral topical anaesthetics: a review. J Dent. 2000 Jan;28(1):3-14. doi: 10.1016/s0300-5712(99)00041-x.
PubMed 10666956Gondim DGA, Montagner AM, Pita-Neto IC, Bringel RJS, Sandrini FAL, Moreno EFC, de Sousa AM, Correia AB. Comparative Analysis of the Effectiveness of the Topical Administration of Benzocaine and EMLA(R) on Oral Pain and Tactile Sensitivity. Int J Dent. 2018 Feb 7;2018:7916274. doi: 10.1155/2018/7916274. eCollection 2018.
PubMed 29593794Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.
PubMed 28879311Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation. J Am Dent Assoc. 2009 Jan;140(1):68-72; quiz 112-3. doi: 10.14219/jada.archive.2009.0020.
PubMed 19119169Fuzier R, Lapeyre-Mestre M, Mertes PM, Nicolas JF, Benoit Y, Didier A, Albert N, Montastruc JL; French Association of Regional Pharmacovigilance Centers. Immediate- and delayed-type allergic reactions to amide local anesthetics: clinical features and skin testing. Pharmacoepidemiol Drug Saf. 2009 Jul;18(7):595-601. doi: 10.1002/pds.1758.
PubMed 19402039Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
PubMed 26379379Jayasuriya NSS, Weerapperuma ID, Amarasinghe MGCK. The use of an iced cotton bud as an effective pre-cooling method for palatal anaesthesia: A technical note. Singapore Dent J. 2017 Dec;38:17-19. doi: 10.1016/j.sdj.2017.07.001.
PubMed 29229069Bose S, Garg N, Pathivada L, Yeluri R. Cooling the soft tissue and its effect on perception of pain during infiltration and block anesthesia in children undergoing dental procedures: A comparative study. J Dent Res Dent Clin Dent Prospects. 2019 Summer;13(3):159-165. doi: 10.15171/joddd.2019.025. Epub 2019 Oct 7.
PubMed 31857860Tirupathi SP, Rajasekhar S. Effect of precooling on pain during local anesthesia administration in children: a systematic review. J Dent Anesth Pain Med. 2020 Jun;20(3):119-127. doi: 10.17245/jdapm.2020.20.3.119. Epub 2020 Jun 24.
PubMed 32617406Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for musculoskeletal injury. Postgrad Med. 2015 Jan;127(1):57-65. doi: 10.1080/00325481.2015.992719. Epub 2014 Dec 15.
PubMed 25526231van Wijk AJ, Hoogstraten J. Anxiety and pain during dental injections. J Dent. 2009 Sep;37(9):700-4. doi: 10.1016/j.jdent.2009.05.023. Epub 2009 May 27.
PubMed 19556053Harbert H. Topical ice: a precursor to palatal injections. J Endod. 1989 Jan;15(1):27-8. doi: 10.1016/S0099-2399(89)80094-9.
PubMed 2607263
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pre Injection Use of Cryoanesthesia as Compared to Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections
- ClinicalTrials.gov ID
- NCT06165432
- Acronym / sponsor ID
- 556/077/078
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to assess the effectiveness of pre-injection use of topical ice application in decreasing pain perception when administering greater palatine nerve block injections as compared to that of topical 20 % benzocaine anesthetic gel using Visual Analogue Scale (VAS) for subjective pain assessment and Sound, Eye, Motor (SEM) scale for objective pain assessment in adult patients.
The main question it aims to answer are:
- Does topical cooling reduce pain as effectively as topical benzocaine during greater palatine nerve block injections?
- Is there any adverse reactions during and after application of topical ice and 20 % benzocaine gel?
- Is there any difference in patient acceptability to the use of either methods during the administration of greater palatine nerve block.
A split mouth design was used where an anesthetic injection was administered in the left and right posterior palatal area. The same operator administered the injections so as to standardize the flow rate and delivery style. The method of intervention i.e topical ice or topical 20% benzocaine anesthetic gel was randomly allocated to the patient by lottery method. The participants received two palatal injections with an interval of two weeks between the appointments. The subjective pain response of the patients during greater palatine nerve block injection with pre-injection use of topical ice and topical anesthetic gel (20% benzocaine) was recorded using VAS scale. The objective pain response of the patients were recorded by a blinded single observer using SEM scale on the same day of the appointment.
Technique of application of topical ice: A new pack of sterile cotton swabstick that was injected with 0.5ml commercially available bottled water and then freezed the day before the appointment. At the time of intervention the injection site was dried with gauge piece and the frozen cotton swab stick was held by its wooden part and the frozen cotton end was placed on the proposed anesthetic site (palatal mucosa just anterior to the greater palatine foramen) for 1 minute. With the frozen cotton swabstick in place, an injection of 0.5 mL of 2 percent Lidocaine with 1:200,000 epinephrine was administered into the injection site via a 27-gauge short needle.
Technique of application of topical anesthetic gel: After the oral mucosa was dried with a gauze piece, application of 0.2 mL Benzocaine 20% gel was done with a sterile swab stick on the proposed anesthetic site (palatal mucosa just anterior to the greater palatine foramen) for a period of two minutes as shown in figure. With the cotton swabstick in place an injection of 0.5 mL of 2 percent Lidocaine with 1:200,000 epinephrine was administered into the injection site via a 27-gauge short needle.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cross sectional comparative split mouth study
| Arm | Type | Receives |
|---|---|---|
| Drug Arm :Topical benzocaine | Active comparator | Drug: Topical Benzocainesince its a split mouth study one half of the hard palate will receive topical benzocaine i.e Group A |
| Topical ice | Active comparator | Other: Topical iceOther half of the palate will receive topical ice i.e Group B |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinically healthy patients ASA I and ASA II with intact palatal mucosa on both sides
- Procedures that needs administration of greater palatine nerve block
Key exclusion criteria (5 listed)
- Hypersensitivity to local anesthetic agent
- Patient who are physically and mentally sub normal
- Presence of palatal mucosal lesions
- Patients on long term neuromodulators for chronic pain
- Patient not consenting to participate in 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 |
|---|---|---|
| Topical BenzocaineBenzocaine topical anesthetic gel will be used a pre-injection anesthetic on one half of the palate before giving greater palatine nerve block | Drug | Drug Arm :Topical benzocaine |
| Topical iceFor the other half of the palate topical ice would be used before greater palatine nerve block | Other | Topical ice |
Primary outcome
subjective pain perception during greater palatine nerve block injection
Time frame: Immediatley after the injection
measured using Visual analogue Scale (VAS) - The Visual Analogue Scale (VAS) consisting of a 100 mm straight line with the endpoints marked to denote extreme limits on the left as 'no pain at all' and on the right as 'pain as bad as it could be' was used to record the pain score . The patient was asked to mark their pain level on the line between the two endpoints after receiving the palatal injection. The distance between 'no pain at all' and the mark defined the subject's pain which was measured in millimeters.
objective pain perception during greater palatine nerve block injection
Time frame: During the injection procedure
measured using Sound, Eye and Motor (SEM) scale -The SEM scale was used in the assessment of the relationship between pain and the reactions which the sensation of pain generates in the patient's eyes, bodily movements and verbal expressions of discomfort
2 secondary outcomes
Adverse effects
Time frame: upto 30 minutes after the injection
Acceptability regarding the use of either topical ice or topical benzocaine
Time frame: 5 minutes after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 31842771Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
- Background: PubMed 26957683Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
- Background: PubMed 26702198Kumar M, Chawla R, Goyal M. Topical anesthesia. J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):450-6. doi: 10.4103/0970-9185.169049.
- Background: PubMed 10666956Meechan JG. Intra-oral topical anaesthetics: a review. J Dent. 2000 Jan;28(1):3-14. doi: 10.1016/s0300-5712(99)00041-x.
- Background: PubMed 29593794Gondim DGA, Montagner AM, Pita-Neto IC, Bringel RJS, Sandrini FAL, Moreno EFC, de Sousa AM, Correia AB. Comparative Analysis of the Effectiveness of the Topical Administration of Benzocaine and EMLA(R) on Oral Pain and Tactile Sensitivity. Int J Dent. 2018 Feb 7;2018:7916274. doi: 10.1155/2018/7916274. eCollection 2018.
- Background: PubMed 28879311Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.
- Background: PubMed 19119169Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation. J Am Dent Assoc. 2009 Jan;140(1):68-72; quiz 112-3. doi: 10.14219/jada.archive.2009.0020.
- Background: PubMed 19402039Fuzier R, Lapeyre-Mestre M, Mertes PM, Nicolas JF, Benoit Y, Didier A, Albert N, Montastruc JL; French Association of Regional Pharmacovigilance Centers. Immediate- and delayed-type allergic reactions to amide local anesthetics: clinical features and skin testing. Pharmacoepidemiol Drug Saf. 2009 Jul;18(7):595-601. doi: 10.1002/pds.1758.
- Background: PubMed 26379379Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
- Background: PubMed 29229069Jayasuriya NSS, Weerapperuma ID, Amarasinghe MGCK. The use of an iced cotton bud as an effective pre-cooling method for palatal anaesthesia: A technical note. Singapore Dent J. 2017 Dec;38:17-19. doi: 10.1016/j.sdj.2017.07.001.
- Background: PubMed 31857860Bose S, Garg N, Pathivada L, Yeluri R. Cooling the soft tissue and its effect on perception of pain during infiltration and block anesthesia in children undergoing dental procedures: A comparative study. J Dent Res Dent Clin Dent Prospects. 2019 Summer;13(3):159-165. doi: 10.15171/joddd.2019.025. Epub 2019 Oct 7.
- Background: PubMed 32617406Tirupathi SP, Rajasekhar S. Effect of precooling on pain during local anesthesia administration in children: a systematic review. J Dent Anesth Pain Med. 2020 Jun;20(3):119-127. doi: 10.17245/jdapm.2020.20.3.119. Epub 2020 Jun 24.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Mehul Jaisani, MDS study chair
B.P. Koirala Insititute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Benzocaine and Topical ice in people with Pain, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 2 inclusion and 5 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 11 Dec 2023. 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 Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
subjective pain perception during greater palatine nerve block injection (time frame: Immediatley after the injection). 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?
On the ClinicalTrials.gov record for NCT06165432, which also lists 32 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 11 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.