Cystic FibrosisPhase 3NCT00297167

Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

A Phase 3 study testing EUR-1008 (APT-1008) in people with Cystic Fibrosis and Exocrine Pancreatic Insufficiency, run by Forest Laboratories at 1 site in United States.

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

The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency… Read more about this study

Who is it for?: Ages 7 years and older
Conditions the study is for: Cystic Fibrosis, Exocrine Pancreatic Insufficiency
What is being tested?: EUR-1008 (APT-1008)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: May 2006to Nov 2006
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 7 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participants with age greater than or equal to (>=) 7 years at the time of enrollment
Participants with weight 70 kg or less and be in an adequate nutritional status as indicated by a body mass index (BMI) >=20 kg/m^2 for ages 18 and above, or a BMI above the twenty fifth percentile for participants aged 7 to 17 years
Participants with confirmed diagnosis of CF who have 2 clinical features consistent with CF, and have either a genotype with 2 identifiable mutations consistent with CF or a sweat chloride concentration that is more than 60 milliequivalent per liter by quantitative pilocarpine iontophoresis
Participants with confirmed diagnosis of EPI who are currently receiving treatment with a commercially available PEP and have documented with a fecal elastase of <100 microgram per gram stool (if no documentation was available, a stool sample was taken at Screening for determination of fecal elastase).
Clinically stable participants with no evidence of acute respiratory disease or any other acute condition
Participants who are willing and able to interrupt current CF treatment for CF-related malabsorption along with any medications that may affect gastric motility or stomach power of hydrogen (pH)

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Participants 18 years of age and older had to a) understand the requirements of the study, b) provide written informed consent, c) agree to abide by the study restrictions, and d) return for the required assessments
Participants 7 to 17 years of age must have a parent(s) or legal guardian who provides written informed consent, agree to abide by the study restrictions
Females participants of childbearing potential must have a negative serum pregnancy test at screening and must agree to use adequate birth control during the study

Who cannot join

Participants with fibrosing colonopathy, hyperuricemia or hyperuricosuria
Participants who are allergic to pork or other porcine PEPs
Participants with forced expiratory volume (FEV1) <30 percent of predicted FEV1 at screening
Participants with any acute systemic administration of an antibiotic for any reason in the previous 4 weeks; however, a low stable dose of an antibiotic or chronic treatment with an inhalatory antibiotic is allowed
Participants with hepatic insufficiency as defined by history or presence of ascites or serum albumin level of < 3.0 milligram/deciliter, or a coagulopathy with an international normalized ratio that is greater than 1.7
Participants who have used an acute dose of any steroid in the previous 2 weeks; however, low chronic doses of a steroid is allowed

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Participants with history of or current diagnosis of distal ileal obstruction syndrome (DIOS) as evidenced or suggested by constipation, abdominal pain, anorexia, early satiety, recurrent vomiting, and palpable fecal mass on physical examination (the absence of DIOS will be confirmed by an X-ray of the abdomen taken at screening)
Participants with any solid organ transplant or surgery affecting the bowel. Participants with a history of appendectomy and inguinal (non-incarcerated) hernioplasty or meconium ileus without the need for bowel resection could be enrolled. Gastrointestinal-tube-fed patients, in absence of dumping syndrome, were also eligible
Participants with history of or current screening evaluation of hyperglycemia as defined by an 8-hour fasting blood glucose (FBG) of >126 mg/dL, or of CF-related diabetes as determined according to the Cystic Fibrosis Foundation (CFF) Consensus Conference of January 1999 (Section IX Part II), that is: a) FBG >126 mg/dL (7.0 millimoles per liter [mmol/L]) on two or more occasions b)FBG >126 mg/dL (7.0 mmol/L) plus casual (without regard to time of day or last meal consumed) glucose level >200 mg/dL (11.1 mmol/L) c)Casual (previously called random) glucose levels >200 mg/dL (11.1 mmol/L) on two or more occasions with symptoms
Participants using an enzyme preparation in excess of 10,000-lipase units/kg/day
Participants using an immunosuppressive drug
Participants who are expecting an inability to tolerate the washout period and/or the placebo treatment
Participants participating in an investigational study of a drug, biologic, or device not currently approved for marketing, within 30 days of screening visit
Female participants who are pregnant or breastfeeding, or unwilling to use effective birth control during study
Participants with any condition that would, in the investigator's opinion, limit the participant's ability to complete the study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Center at Tyler
Tyler, Texas, 75708

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

Read the detailed description

This is a randomized, double-blind, placebo-controlled, 2-treatment, crossover, multicenter trial in participants with CF and EPI. The study consists of a screening period (1 to 14 days), a washout period (2 days), a dose titration/stabilization period (6 to 9 days), a blinded randomized treatment period (6 to 7 days), an open-label normalization period 1 (5 to 14 days), a blinded crossover treatment period (6 to 7 days), followed by an open-label normalization period 2 (7 days). The order of treatments (placebo followed by EUR-1008 [APT-1008] or EUR-1008 [APT-1008] followed by placebo) will be determined by randomization at the beginning of randomization treatment period only and will be carried through the crossover treatment period. The starting dose will be 1,000 lipase units per kilogram per meal (lipase units/kg/meal), which will be titrated to control symptoms of EPI, with the total dose not exceeding 10,000 lipase units/kg/day.

Conditions: Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Being tested: EUR-1008 (APT-1008), Placebo
Keywords: CF, Cystic Fibrosis, EPI, Exocrine Pancreatic Insufficiency, Pancreatic, Enzyme, PEP
Medical subject headings: Cystic Fibrosis, Exocrine Pancreatic Insufficiency

What participants receive

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

EUR-1008 (APT-1008)Drug
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
PlaceboDrug
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
PlaceboDrug
Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.
EUR-1008 (APT-1008)Drug
EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.

Study groups in NCT00297167
Study group	Role	What they receive
EUR-1008 (APT-1008) First, Then Placebo	Experimental	Not described Receives: Drug: EUR-1008 (APT-1008); Drug: Placebo
Placebo First, Then EUR-1008 (APT-1008)	Experimental	Not described Receives: Drug: Placebo; Drug: EUR-1008 (APT-1008)

What is being measured

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

Percent Coefficient of Fat Absorption (CFA%)
Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.
Measured: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods

Secondary outcomes (7)

Percent Coefficient of Nitrogen Absorption (CNA%)
Percent CNA was calculated as ([nitrogen intake-nitrogen excretion]/nitrogen intake)*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.
Measured: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods
Lipid Levels
Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.
Measured: End of treatment (Day 6 during first and second double-blind intervention periods)
Vitamin A Levels
Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.
Measured: End of treatment (Day 6 during first and second double-blind intervention periods)
Vitamin E Levels
Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.
Measured: End of treatment (Day 6 during first and second double-blind intervention periods)
Mean Daily Number of Stools
Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.
Measured: Day 3 up to Day 6 during first and second double-blind intervention periods
Percentage of Stool Categorized as Per Consistency
Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.
Measured: Day 3 up to Day 6 during first and second double-blind intervention periods
Mean Number of Abdominal Symptoms
Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.
Measured: Day 3 up to Day 6 during first and second double-blind intervention periods

Timeline

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

May 2006Nov 2006

First posted28 Feb 2006 (estimated)
Study startMay 2006
Primary completionNov 2006
Study completionNov 2006

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 (1)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies 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: Crossover
Masking: Double blind
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00297167
Sponsor's protocol ID: EUR-1008-M
Status last verified: Feb 2017
First submitted: 27 Feb 2006
Last updated: 16 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Wooldridge JL, Heubi JE, Amaro-Galvez R, Boas SR, Blake KV, Nasr SZ, Chatfield B, McColley SA, Woo MS, Hardy KA, Kravitz RM, Straforini C, Anelli M, Lee C. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009 Dec;8(6):405-17. doi: 10.1016/j.jcf.2009.07.006. Epub 2009 Aug 15.
PubMed 19683970

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 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
ClinicalTrials.gov ID: NCT00297167
Acronym / sponsor ID: EUR-1008-M
Conditions: Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Keywords: CF, Cystic Fibrosis, EPI, Exocrine Pancreatic Insufficiency, Pancreatic, Enzyme, PEP
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Nov 2006 (actual)
Study completion: Nov 2006 (actual)
First posted: 28 Feb 2006 (estimated)
Results: Posted 4 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
EUR-1008 (APT-1008) First, Then Placebo	Experimental	Drug: EUR-1008 (APT-1008), Drug: Placebo
Placebo First, Then EUR-1008 (APT-1008)	Experimental	Drug: Placebo, Drug: EUR-1008 (APT-1008)

Who may qualify

Ages: 7 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Participants with age greater than or equal to (>=) 7 years at the time of enrollment
Participants with weight 70 kg or less and be in an adequate nutritional status as indicated by a body mass index (BMI) >=20 kg/m^2 for ages 18 and above, or a BMI above the twenty fifth percentile for participants aged 7 to 17 years
Participants with confirmed diagnosis of CF who have 2 clinical features consistent with CF, and have either a genotype with 2 identifiable mutations consistent with CF or a sweat chloride concentration that is more than 60 milliequivalent per liter by quantitative pilocarpine iontophoresis
Participants with confirmed diagnosis of EPI who are currently receiving treatment with a commercially available PEP and have documented with a fecal elastase of <100 microgram per gram stool (if no documentation was available, a stool sample was taken at Screening for determination of fecal elastase).
Clinically stable participants with no evidence of acute respiratory disease or any other acute condition

Key exclusion criteria (15 listed)

Participants with fibrosing colonopathy, hyperuricemia or hyperuricosuria
Participants who are allergic to pork or other porcine PEPs
Participants with forced expiratory volume (FEV1) <30 percent of predicted FEV1 at screening
Participants with any acute systemic administration of an antibiotic for any reason in the previous 4 weeks; however, a low stable dose of an antibiotic or chronic treatment with an inhalatory antibiotic is allowed
Participants with hepatic insufficiency as defined by history or presence of ascites or serum albumin level of < 3.0 milligram/deciliter, or a coagulopathy with an international normalized ratio that is greater than 1.7

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
EUR-1008 (APT-1008)EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.	Drug	EUR-1008 (APT-1008) First, Then Placebo
PlaceboPlacebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.	Drug	EUR-1008 (APT-1008) First, Then Placebo
PlaceboPlacebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.	Drug	Placebo First, Then EUR-1008 (APT-1008)
EUR-1008 (APT-1008)EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.	Drug	Placebo First, Then EUR-1008 (APT-1008)

Primary outcome

Percent Coefficient of Fat Absorption (CFA%)
Time frame: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods
Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.

7 secondary outcomes

Percent Coefficient of Nitrogen Absorption (CNA%)
Time frame: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods
Lipid Levels
Time frame: End of treatment (Day 6 during first and second double-blind intervention periods)
Vitamin A Levels
Time frame: End of treatment (Day 6 during first and second double-blind intervention periods)
Vitamin E Levels
Time frame: End of treatment (Day 6 during first and second double-blind intervention periods)
Mean Daily Number of Stools
Time frame: Day 3 up to Day 6 during first and second double-blind intervention periods
Percentage of Stool Categorized as Per Consistency
Time frame: Day 3 up to Day 6 during first and second double-blind intervention periods
Mean Number of Abdominal Symptoms
Time frame: Day 3 up to Day 6 during first and second double-blind intervention periods

Results and safety

Results posted to the registry on 4 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First, Then EUR-1008 (APT-1008)	17	17
EUR-1008 (APT-1008) First, Then Placebo	16	16
EUR-1008 (APT-1008) (Open-label)	0	0

Primary outcome: Percent Coefficient of Fat Absorption (CFA%)

Time frame: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods. Least squares mean (Standard Error). Unit: percent CFA

Measure	EUR-1008 (APT-1008) n = 32	Placebo n = 31
Value	88.28 (2.599)	62.76 (2.639)

EUR-1008 (APT-1008) vs Placebo: Least Square (LS) Mean Difference: -25.52 (95% CI -31.73 to -19.32), p <0.001, ANOVA

Population analysed: Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EUR-1008 (APT-1008)	2 of 34 (5.9%)	19 of 34 (55.9%)	Not reported
Placebo	0 of 32 (0%)	16 of 32 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19683970Wooldridge JL, Heubi JE, Amaro-Galvez R, Boas SR, Blake KV, Nasr SZ, Chatfield B, McColley SA, Woo MS, Hardy KA, Kravitz RM, Straforini C, Anelli M, Lee C. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009 Dec;8(6):405-17. doi: 10.1016/j.jcf.2009.07.006. Epub 2009 Aug 15.

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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.

Aptalis Medical Information study director

Forest Laboratories

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EUR-1008 (APT-1008) in people with Cystic Fibrosis and Exocrine Pancreatic Insufficiency, run by Forest Laboratories 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 9 inclusion and 15 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 16 Mar 2017. 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. 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 4 Apr 2014). 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?

Percent Coefficient of Fat Absorption (CFA%) (time frame: Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods). 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 NCT00297167, which also lists 1 linked publication.

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 16 Mar 2017.