ColonoscopyPhase 4NCT01967433
Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
A Phase 4 study testing Diphenhydramine in people with Colonoscopy and Adjunct Anesthesia Medication, run by University of Oklahoma at 1 site in United States.
Trial summary
To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce the amount of standard sedatives used during colonoscopy in patients on chronic opioids. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Colonoscopy, Adjunct Anesthesia Medication
- What is being tested?
- Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy
- Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months
Who cannot join
- Inability to execute informed consent
- Allergy to Diphenhydramine, fentanyl or midazolam
- Known or suspected pregnancy
- Endoscopic procedure without sedation
- Patient scheduled to have other endoscopic procedures on the same day
- Prior alimentary tract surgery
- Severe cardiopulmonary disease (ASA IV)
- Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Use of Diphenhydramine as an Adjunctive Sedative for Colonoscopy in Patients Chronically on Opioids
To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce the amount of standard sedatives used during colonoscopy in patients on chronic opioids.
Read the detailed description
Specific Aims:
The primary aim of our study is to determine if addition of Diphenhydramine to Fentanyl and Midazolam will decrease the dose of Fentanyl and Midazolam used during colonoscopy in individuals on chronic opioids. Secondarily we will be looking at quality of sedation, duration of colonoscopy, time to reach cecum and adverse effects (hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, hypotension defined as systolic BP less than 90 mmhg and use of reversal agents i.e Naloxone or Flumazenil).
Day of Procedure:
After consent is obtained the medical records of the patients will be reviewed and demographic information, co-morbidities, current medication will be extracted and recorded.
On the day of colonoscopy Alcohol use disorder inventory (AUDIT) will be used to screen for alcohol abuse. AUDIT was developed by World Health Organization and has been validated over a period of 2 decades. It consist of 10 questions, each question is scored 0-4 on the basis of subjects alcohol use. It takes about 2-4 minutes to complete. A score 10 or greater is highly specific or alcohol use.
Subjects will be checked in and prepared according to routine protocols of the VA medical center. Participants will be randomly assigned to receive either 50 mg of diphenhydramine or 10 ml of 0.9% sodium chloride. On the day of colonoscopy randomization will be performed by an independent investigator who is a pharmacist at VA medical center using the website http://www.randomization.com. She will also prepare and dispense medication. Each endoscopy team will consist of an attending gastroenterologist, gastroenterology fellow and two nurses. Medications will be administered by one of the nurses under the direct supervision of the physician.
At the start of procedure baseline vitals will be recorded as per our unit's policy. Research medication will be administered 3 minutes prior to administration of other medications. Neither the patient nor the medical staff including the endoscopist will be aware of the contents of the vial. Conscious sedation will be achieved using a combination of intravenous midazolam and fentanyl as standard sedative. Rarely, additional diphenhydramine will be given, on the basis of the judgment of the endoscopist. During the procedure vital signs including oxygen saturation will be monitored at 3-5 minute interval. Procedure related complications, including hypotension, desaturation and cardiac arrhythmia will be managed according to our endoscopy unit policy and protocols.
Following the procedure, the nurse and the fellow or the attending will individually rate the quality if sedation on a ten-point Likert scale. Qualitative assessment will also be made (Under-sedated, adequately sedated, or over-sedated).
Recovery time will be recorded.
Day Following the Colonoscopy Twenty-four hour discharge a follow up call will be made and the patients will be asked to evaluate the level of sedation on a 10-point scale (1, inadequate; 10 completely without discomfort); pain (1, no pain; 10 severe pain), and amnesia (10, no memory of the procedure; 1 complete memory).
- Conditions
- Colonoscopy, Adjunct Anesthesia Medication
- Being tested
- Diphenhydramine, Placebo
- Keywords
- Fentanyl, Midazolam, Sedation, Patient tolerance, Duration of colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenhydramineDrug
Also called Benadryl
PlaceboDrug
Also called Normal Saline, 0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Diphenhydramine | Experimental | Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives Receives: Drug: Diphenhydramine |
| Placebo | Placebo comparator | 0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of Fentanyl
Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.
Measured: From induction (first dose of sedative) to end of procedure
Secondary outcomes (6)
Quality of Sedation
Quality of sedation will be accessed by the nurse and the physician at the end of procedure.
Name: 10 point visual analogue scale Minimum score: 1 (worse) Maximum score: 10 (better)
Measured: During the colonoscopy and 24 hours after discharge
Duration of Procedure
Induction period (time from first dose of fentanyl to scope insertion), procedural time (time from scope insertion to scope out), and recovery time (time from scope out to discharge) were recorded by the nursing staff in their standard documentation.
Measured: Time from induction (first dose of sedative) to discharge
Number of Participants With Adverse Events
Following adverse events will be recorded: (1)Hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, (2)hypotension defined as systolic BP less than 90 mmhg and (3)use of reversal agents i.e Naloxone or Flumazenil
Measured: From induction (first dose of sedative) to discharge
24 Hour Follow up Pain Score
At 24 hr follow up patients were asked to rate the level of pain during the procedure using 10 point scale.
10 point visual analogue scale minimum= 0 (better) maximum =10 (worse)
Measured: About 24 hours after the procedure
Dosage of Midazolam
Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.
Measured: From induction (first dose of sedative) to end of procedure
24 Hour Follow up Amnesia Score
Patient were also asked to rate amnesia on a 10 point scale 24 after discharge. minimum= 0 (worse) maximum =10 (better)
Measured: At about 24 after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2018
- Study completionJul 2018
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 (11)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salman Nusrat, MD, Study director, University of OklahomaMohammad Madhoun, MD MS, Principal investigator, Univeristy of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967433
- Sponsor's protocol ID
- DAASIPCO
- Status last verified
- Mar 2020
- First submitted
- 11 Oct 2013
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.
PubMed 15330904Zubarik R, Ganguly E, Benway D, Ferrentino N, Moses P, Vecchio J. Procedure-related abdominal discomfort in patients undergoing colorectal cancer screening: a comparison of colonoscopy and flexible sigmoidoscopy. Am J Gastroenterol. 2002 Dec;97(12):3056-61. doi: 10.1111/j.1572-0241.2002.07101.x.
PubMed 12492190Bergeron P, Enns J, Delima L, Dupuis JY, Wynands JE. Effects of routine premedication for cardiac catheterization on sedation, level of anxiety and arterial oxygen saturation. Can J Cardiol. 1995 Mar;11(3):201-5.
PubMed 7889437Cook PJ, Flanagan R, James IM. Diazepam tolerance: effect of age, regular sedation, and alcohol. Br Med J (Clin Res Ed). 1984 Aug 11;289(6441):351-3. doi: 10.1136/bmj.289.6441.351.
PubMed 6432093Pena LR, Mardini HE, Nickl NJ. Development of an instrument to assess and predict satisfaction and poor tolerance among patients undergoing endoscopic procedures. Dig Dis Sci. 2005 Oct;50(10):1860-71. doi: 10.1007/s10620-005-2952-7.
PubMed 16187188Keeffe EB, O'Connor KW. 1989 A/S/G/E survey of endoscopic sedation and monitoring practices. Gastrointest Endosc. 1990 May-Jun;36(3 Suppl):S13-8.
PubMed 2351253Hirsh I, Vaissler A, Chernin J, Segol O, Pizov R. Fentanyl or tramadol, with midazolam, for outpatient colonoscopy: analgesia, sedation, and safety. Dig Dis Sci. 2006 Nov;51(11):1946-51. doi: 10.1007/s10620-006-9413-9. Epub 2006 Sep 29.
PubMed 17009113Tu RH, Grewall P, Leung JW, Suryaprasad AG, Sheykhzadeh PI, Doan C, Garcia JC, Zhang N, Prindiville T, Mann S, Trudeau W. Diphenhydramine as an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastrointest Endosc. 2006 Jan;63(1):87-94. doi: 10.1016/j.gie.2005.08.015.
PubMed 16377322Roach CL, Husain N, Zabinsky J, Welch E, Garg R. Moderate sedation for echocardiography of preschoolers. Pediatr Cardiol. 2010 May;31(4):469-73. doi: 10.1007/s00246-009-9622-z. Epub 2010 Jan 3.
PubMed 20047024Hofmeister EH, Egger CM. Evaluation of diphenhydramine as a sedative for dogs. J Am Vet Med Assoc. 2005 Apr 1;226(7):1092-4. doi: 10.2460/javma.2005.226.1092.
PubMed 15825733Husain Z, Hussain K, Nair R, Steinman R. Diphenhydramine induced QT prolongation and torsade de pointes: An uncommon effect of a common drug. Cardiol J. 2010;17(5):509-11.
PubMed 20865683
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diphenhydramine as an Adjunctive Sedative for Colonoscopy in Patients Chronically on Opioids
- ClinicalTrials.gov ID
- NCT01967433
- Acronym / sponsor ID
- DAASIPCO
- Conditions
- Colonoscopy, Adjunct Anesthesia Medication
- Keywords
- Fentanyl, Midazolam, Sedation, Patient tolerance, Duration of colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce the amount of standard sedatives used during colonoscopy in patients on chronic opioids.
Detailed description
Specific Aims:
The primary aim of our study is to determine if addition of Diphenhydramine to Fentanyl and Midazolam will decrease the dose of Fentanyl and Midazolam used during colonoscopy in individuals on chronic opioids. Secondarily we will be looking at quality of sedation, duration of colonoscopy, time to reach cecum and adverse effects (hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, hypotension defined as systolic BP less than 90 mmhg and use of reversal agents i.e Naloxone or Flumazenil).
Day of Procedure:
After consent is obtained the medical records of the patients will be reviewed and demographic information, co-morbidities, current medication will be extracted and recorded.
On the day of colonoscopy Alcohol use disorder inventory (AUDIT) will be used to screen for alcohol abuse. AUDIT was developed by World Health Organization and has been validated over a period of 2 decades. It consist of 10 questions, each question is scored 0-4 on the basis of subjects alcohol use. It takes about 2-4 minutes to complete. A score 10 or greater is highly specific or alcohol use.
Subjects will be checked in and prepared according to routine protocols of the VA medical center. Participants will be randomly assigned to receive either 50 mg of diphenhydramine or 10 ml of 0.9% sodium chloride. On the day of colonoscopy randomization will be performed by an independent investigator who is a pharmacist at VA medical center using the website http://www.randomization.com. She will also prepare and dispense medication. Each endoscopy team will consist of an attending gastroenterologist, gastroenterology fellow and two nurses. Medications will be administered by one of the nurses under the direct supervision of the physician.
At the start of procedure baseline vitals will be recorded as per our unit's policy. Research medication will be administered 3 minutes prior to administration of other medications. Neither the patient nor the medical staff including the endoscopist will be aware of the contents of the vial. Conscious sedation will be achieved using a combination of intravenous midazolam and fentanyl as standard sedative. Rarely, additional diphenhydramine will be given, on the basis of the judgment of the endoscopist. During the procedure vital signs including oxygen saturation will be monitored at 3-5 minute interval. Procedure related complications, including hypotension, desaturation and cardiac arrhythmia will be managed according to our endoscopy unit policy and protocols.
Following the procedure, the nurse and the fellow or the attending will individually rate the quality if sedation on a ten-point Likert scale. Qualitative assessment will also be made (Under-sedated, adequately sedated, or over-sedated).
Recovery time will be recorded.
Day Following the Colonoscopy Twenty-four hour discharge a follow up call will be made and the patients will be asked to evaluate the level of sedation on a 10-point scale (1, inadequate; 10 completely without discomfort); pain (1, no pain; 10 severe pain), and amnesia (10, no memory of the procedure; 1 complete memory).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diphenhydramine | Experimental | Drug: DiphenhydramineDiphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives |
| Placebo | Placebo comparator | Drug: Placebo0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy
- Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months
Key exclusion criteria (8 listed)
- Inability to execute informed consent
- Allergy to Diphenhydramine, fentanyl or midazolam
- Known or suspected pregnancy
- Endoscopic procedure without sedation
- Patient scheduled to have other endoscopic procedures on the same day
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 |
|---|---|---|
| DiphenhydramineAlso: Benadryl | Drug | Diphenhydramine |
| PlaceboAlso: Normal Saline, 0.9% sodium chloride | Drug | Placebo |
Primary outcome
Dosage of Fentanyl
Time frame: From induction (first dose of sedative) to end of procedure
Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.
6 secondary outcomes
Quality of Sedation
Time frame: During the colonoscopy and 24 hours after discharge
Duration of Procedure
Time frame: Time from induction (first dose of sedative) to discharge
Number of Participants With Adverse Events
Time frame: From induction (first dose of sedative) to discharge
24 Hour Follow up Pain Score
Time frame: About 24 hours after the procedure
Dosage of Midazolam
Time frame: From induction (first dose of sedative) to end of procedure
24 Hour Follow up Amnesia Score
Time frame: At about 24 after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15330904Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.
- Background: PubMed 12492190Zubarik R, Ganguly E, Benway D, Ferrentino N, Moses P, Vecchio J. Procedure-related abdominal discomfort in patients undergoing colorectal cancer screening: a comparison of colonoscopy and flexible sigmoidoscopy. Am J Gastroenterol. 2002 Dec;97(12):3056-61. doi: 10.1111/j.1572-0241.2002.07101.x.
- Background: PubMed 7889437Bergeron P, Enns J, Delima L, Dupuis JY, Wynands JE. Effects of routine premedication for cardiac catheterization on sedation, level of anxiety and arterial oxygen saturation. Can J Cardiol. 1995 Mar;11(3):201-5.
- Background: PubMed 6432093Cook PJ, Flanagan R, James IM. Diazepam tolerance: effect of age, regular sedation, and alcohol. Br Med J (Clin Res Ed). 1984 Aug 11;289(6441):351-3. doi: 10.1136/bmj.289.6441.351.
- Background: PubMed 16187188Pena LR, Mardini HE, Nickl NJ. Development of an instrument to assess and predict satisfaction and poor tolerance among patients undergoing endoscopic procedures. Dig Dis Sci. 2005 Oct;50(10):1860-71. doi: 10.1007/s10620-005-2952-7.
- Background: PubMed 2351253Keeffe EB, O'Connor KW. 1989 A/S/G/E survey of endoscopic sedation and monitoring practices. Gastrointest Endosc. 1990 May-Jun;36(3 Suppl):S13-8.
- Background: PubMed 17009113Hirsh I, Vaissler A, Chernin J, Segol O, Pizov R. Fentanyl or tramadol, with midazolam, for outpatient colonoscopy: analgesia, sedation, and safety. Dig Dis Sci. 2006 Nov;51(11):1946-51. doi: 10.1007/s10620-006-9413-9. Epub 2006 Sep 29.
- Background: PubMed 16377322Tu RH, Grewall P, Leung JW, Suryaprasad AG, Sheykhzadeh PI, Doan C, Garcia JC, Zhang N, Prindiville T, Mann S, Trudeau W. Diphenhydramine as an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastrointest Endosc. 2006 Jan;63(1):87-94. doi: 10.1016/j.gie.2005.08.015.
- Background: PubMed 20047024Roach CL, Husain N, Zabinsky J, Welch E, Garg R. Moderate sedation for echocardiography of preschoolers. Pediatr Cardiol. 2010 May;31(4):469-73. doi: 10.1007/s00246-009-9622-z. Epub 2010 Jan 3.
- Background: PubMed 15825733Hofmeister EH, Egger CM. Evaluation of diphenhydramine as a sedative for dogs. J Am Vet Med Assoc. 2005 Apr 1;226(7):1092-4. doi: 10.2460/javma.2005.226.1092.
- Background: PubMed 20865683Husain Z, Hussain K, Nair R, Steinman R. Diphenhydramine induced QT prolongation and torsade de pointes: An uncommon effect of a common drug. Cardiol J. 2010;17(5):509-11.
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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.
Salman Nusrat, MD study director
University of Oklahoma
Mohammad Madhoun, MD MS principal investigator
Univeristy of Oklahoma Health Sciences Center
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 Diphenhydramine in people with Colonoscopy and Adjunct Anesthesia Medication, run by University of Oklahoma 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 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2020). 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?
Dosage of Fentanyl (time frame: From induction (first dose of sedative) to end of procedure). 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 NCT01967433, which also lists 11 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 Mar 2020.