HealthyPhase 1NCT01443169

A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted

A Phase 1 study testing Sequence 1 - Treatment E: Immediate Release Pregabalin in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Sequence 1 - Treatment E: Immediate Release Pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteBelgium
Study dates: Mar 2012to Apr 2012
Phase: Phase 1
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests).
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject or a legally acceptable representative.
Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
History of febrile illness within 5 days prior to the first dose of study medication.
Subjects with an estimated creatinine clearance (CLcr) <60 mL/min derived using the method of Cockcroft and Gault1.
Any condition possibly affecting drug absorption (eg, gastrectomy, irritable bowel syndrome).
A positive urine drug screen.
Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.

Show all 18Show fewer

History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days (for nonhormonal methods) or approximately 3 months (for hormonal contraception) prior to the first dose of study medication and for 28 days after the last dose of study medication.
Use of prescription (other than oral, transdermal, intrauterine, implanted, or injected contraceptives or hormone replacement therapy) or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued at least 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor.
Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
History of sensitivity to pregabalin, gabapentin, or other alpha 2 delta ligands.
History of sensitivity to heparin or heparin induced thrombocytopenia.
Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
Previous participation in a study involving pregabalin.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Subjects with active suicidal ideation or suicidal behavior within 1 year prior to Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or active ideation identified at Screening or on Day 1.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Investigational Site
Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Open Label, Single Dose, 5-treatment, 5- Period Crossover Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release Pregabalin Tablet Formulations Administered Following an Evening Meal and the Immediate Release Formulation Administered Fasted

This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a 330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th period to to estimate and compare the % of dose absorbed versus time profile for the three CR prototype tablets and the CR reference tablet.

Conditions: Healthy
Being tested: Sequence 1 - Treatment A: Controlled Release Pregabalin, Sequence 1 - Treatment B: Controlled Release Pregabalin, Sequence 1 - Treatment C:Controlled Release Pregabalin, Sequence 1 - Treatment D: Controlled Release Pregabalin, Sequence 1 - Treatment E: Immediate Release Pregabalin
Keywords: Pharmacokinetic, relative oral bioavailability, pregabalin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sequence 1 - Treatment A: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment B: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment C:Controlled Release PregabalinDrug
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment D: Controlled Release PregabalinDrug
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 1 - Treatment E: Immediate Release PregabalinDrug
300 mg IR capsule administered in the evening in the fasted state.
Sequence 2 - Treatment B: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment D: Controlled Release PregabalinDrug
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment A: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment C: Controlled Release PregabalinDrug
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 2 - Treatment E: Immediate Release PregabalinDrug
300 mg IR capsule administered in the evening in the fasted state.
Sequence 3 - Treatment C: Controlled Release PregabalinDrug
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment A: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment D: Controlled Release PregabalinDrug
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment B: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 3 - Treatment E: Immediate Release PregabalinDrug
300 mg IR capsule administered in the evening in the fasted state.
Sequence 4 - Treatment D: Controlled Release PregabalinDrug
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment C: Controlled Release PregabalinDrug
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment B: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment A: Controlled Release PregabalinDrug
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
Sequence 4 - Treatment E: Immediate Release PregabalinDrug
300 mg IR capsule administered in the evening in the fasted state.

Study groups in NCT01443169
Study group	Role	What they receive
Sequence 1	Experimental	Not described Receives: Drug: Sequence 1 - Treatment A: Controlled Release Pregabalin; Drug: Sequence 1 - Treatment B: Controlled Release Pregabalin; Drug: Sequence 1 - Treatment C:Controlled Release Pregabalin; Drug: Sequence 1 - Treatment D: Controlled Release Pregabalin; Drug: Sequence 1 - Treatment E: Immediate Release Pregabalin
Sequence 2	Experimental	Not described Receives: Drug: Sequence 2 - Treatment B: Controlled Release Pregabalin; Drug: Sequence 2 - Treatment D: Controlled Release Pregabalin; Drug: Sequence 2 - Treatment A: Controlled Release Pregabalin; Drug: Sequence 2 - Treatment C: Controlled Release Pregabalin; Drug: Sequence 2 - Treatment E: Immediate Release Pregabalin
Sequence 3	Experimental	Not described Receives: Drug: Sequence 3 - Treatment C: Controlled Release Pregabalin; Drug: Sequence 3 - Treatment A: Controlled Release Pregabalin; Drug: Sequence 3 - Treatment D: Controlled Release Pregabalin; Drug: Sequence 3 - Treatment B: Controlled Release Pregabalin; Drug: Sequence 3 - Treatment E: Immediate Release Pregabalin
Sequence 4	Experimental	Not described Receives: Drug: Sequence 4 - Treatment D: Controlled Release Pregabalin; Drug: Sequence 4 - Treatment C: Controlled Release Pregabalin; Drug: Sequence 4 - Treatment B: Controlled Release Pregabalin; Drug: Sequence 4 - Treatment A: Controlled Release Pregabalin; Drug: Sequence 4 - Treatment E: Immediate Release Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under plasma concentration-time curve from time zero extrapolated to infinite time (AUClast)
Measured: predose to 48hr post dose
Area under plasma concentration-time profile from time zero to time of last quantifiable concentration (AUCinf)
Measured: predose to 48hr post dose
Maximum observed concentration within dosing interval (Cmax)
Measured: predose to 48hr post dose
Time for Cmax Tmax
Measured: predose to 48hr post dose
Terminal half-life (t1/2)
Measured: predose to 48hr post dose
Safety endpoints will be evaluated by comparing the incidence and severity of AEs for each of the formulations evaluated
Measured: predose to 48hr post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Apr 2012

First posted29 Sep 2011 (estimated)
Study startMar 2012
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01443169
Sponsor's protocol ID: A0081286
Status last verified: Sep 2018
First submitted: 27 Sep 2011
Last updated: 22 Jan 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open Label, Single Dose, 5-treatment, 5- Period Crossover Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release Pregabalin Tablet Formulations Administered Following an Evening Meal and the Immediate Release Formulation Administered Fasted
ClinicalTrials.gov ID: NCT01443169
Acronym / sponsor ID: A0081286
Conditions: Healthy
Keywords: Pharmacokinetic, relative oral bioavailability, pregabalin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 29 Sep 2011 (estimated)
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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence 1	Experimental	Drug: Sequence 1 - Treatment A: Controlled Release Pregabalin, Drug: Sequence 1 - Treatment B: Controlled Release Pregabalin, Drug: Sequence 1 - Treatment C:Controlled Release Pregabalin, Drug: Sequence 1 - Treatment D: Controlled Release Pregabalin, Drug: Sequence 1 - Treatment E: Immediate Release Pregabalin
Sequence 2	Experimental	Drug: Sequence 2 - Treatment B: Controlled Release Pregabalin, Drug: Sequence 2 - Treatment D: Controlled Release Pregabalin, Drug: Sequence 2 - Treatment A: Controlled Release Pregabalin, Drug: Sequence 2 - Treatment C: Controlled Release Pregabalin, Drug: Sequence 2 - Treatment E: Immediate Release Pregabalin
Sequence 3	Experimental	Drug: Sequence 3 - Treatment C: Controlled Release Pregabalin, Drug: Sequence 3 - Treatment A: Controlled Release Pregabalin, Drug: Sequence 3 - Treatment D: Controlled Release Pregabalin, Drug: Sequence 3 - Treatment B: Controlled Release Pregabalin, Drug: Sequence 3 - Treatment E: Immediate Release Pregabalin
Sequence 4	Experimental	Drug: Sequence 4 - Treatment D: Controlled Release Pregabalin, Drug: Sequence 4 - Treatment C: Controlled Release Pregabalin, Drug: Sequence 4 - Treatment B: Controlled Release Pregabalin, Drug: Sequence 4 - Treatment A: Controlled Release Pregabalin, Drug: Sequence 4 - Treatment E: Immediate Release Pregabalin

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests).
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject or a legally acceptable representative.

Key exclusion criteria (18 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
History of febrile illness within 5 days prior to the first dose of study medication.
Subjects with an estimated creatinine clearance (CLcr) <60 mL/min derived using the method of Cockcroft and Gault1.
Any condition possibly affecting drug absorption (eg, gastrectomy, irritable bowel syndrome).
A positive urine drug screen.

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
Sequence 1 - Treatment A: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 1
Sequence 1 - Treatment B: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 1
Sequence 1 - Treatment C:Controlled Release Pregabalin330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 1
Sequence 1 - Treatment D: Controlled Release Pregabalin330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 1
Sequence 1 - Treatment E: Immediate Release Pregabalin300 mg IR capsule administered in the evening in the fasted state.	Drug	Sequence 1
Sequence 2 - Treatment B: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 2
Sequence 2 - Treatment D: Controlled Release Pregabalin330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 2
Sequence 2 - Treatment A: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 2
Sequence 2 - Treatment C: Controlled Release Pregabalin330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 2
Sequence 2 - Treatment E: Immediate Release Pregabalin300 mg IR capsule administered in the evening in the fasted state.	Drug	Sequence 2
Sequence 3 - Treatment C: Controlled Release Pregabalin330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 3
Sequence 3 - Treatment A: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 3
Sequence 3 - Treatment D: Controlled Release Pregabalin330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 3
Sequence 3 - Treatment B: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 3
Sequence 3 - Treatment E: Immediate Release Pregabalin300 mg IR capsule administered in the evening in the fasted state.	Drug	Sequence 3
Sequence 4 - Treatment D: Controlled Release Pregabalin330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 4
Sequence 4 - Treatment C: Controlled Release Pregabalin330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 4
Sequence 4 - Treatment B: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 4
Sequence 4 - Treatment A: Controlled Release Pregabalin330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.	Drug	Sequence 4
Sequence 4 - Treatment E: Immediate Release Pregabalin300 mg IR capsule administered in the evening in the fasted state.	Drug	Sequence 4

Primary outcome

Area under plasma concentration-time curve from time zero extrapolated to infinite time (AUClast)
Time frame: predose to 48hr post dose
Area under plasma concentration-time profile from time zero to time of last quantifiable concentration (AUCinf)
Time frame: predose to 48hr post dose
Maximum observed concentration within dosing interval (Cmax)
Time frame: predose to 48hr post dose
Time for Cmax Tmax
Time frame: predose to 48hr post dose
Terminal half-life (t1/2)
Time frame: predose to 48hr post dose
Safety endpoints will be evaluated by comparing the incidence and severity of AEs for each of the formulations evaluated
Time frame: predose to 48hr post dose

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 22 Jan 2021.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sequence 1 - Treatment E: Immediate Release Pregabalin in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Belgium.

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 6 inclusion and 18 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 22 Jan 2021. 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 Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Area under plasma concentration-time curve from time zero extrapolated to infinite time (AUClast) (time frame: predose to 48hr post dose). The study lists 6 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 NCT01443169.

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 22 Jan 2021.