Exocrine Pancreatic InsufficiencyPhase 4NCT01327703
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
A Phase 4 study testing Panzytrat® 25,000 and Kreon® 25,000 in people with Exocrine Pancreatic Insufficiency and Cystic Fibrosis, run by Forest Laboratories at 13 sites in 2 countries.
Trial summary
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- What is being tested?
- Panzytrat® 25,000 and Kreon® 25,000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2011to May 2012
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant or his/her legal representative signed informed consent form (ICF) prior to starting any study procedures
- Participant with clinical diagnosis of CF based on one or more typical clinical features of CF phenotype, in addition to one of the following: a genotype that documents the presence of 2 CF-causing mutation, or a sweat chloride test greater than or equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis on two separate occasions
- Participant with severe EPI confirmed by enzyme-linked immunosorbent assay (ELISA) measurement of fecal elastase-1 (FE-1)
- Male or female participant aged 7 years or older
- Participant currently receiving and has received a stable dose of lipase with either Panzytrat® 25,000 or Kreon® 25,000 for at least 30 days prior to ICF signature
- Participant generally in good health, except for the underlying symptoms associated with CF and EPI, and is clinically stable (no change in the last 30 days of physical examination) as evidenced by medical and medication histories, physical examination including vital signs during screening and laboratory tests
- Participant able to maintain a CF standardized diet with a lipid content customized to his/her needs during the study according to the qualification phase diary
- Women of childbearing potential must have a negative pregnancy test at study entry and must use a medically acceptable contraceptive method for the duration of the study
Who cannot join
- Participant with known contraindication, sensitivity or hypersensitivity to Panzytrat® 25,000 or Kreon® 25,000, or to any porcine protein
- Participant who recently received treatment of an emergent acute infection with oral or intravenous (IV) antibiotics that was not stopped at least 14 days prior to randomization
- Participant with chronic use of narcotics that were not stopped at least 7 days prior to the qualification visit
- Participant using of any prohibited medications or products listed in the prohibited medication section of the protocol
- Participant with acute pancreatitis or exacerbation of chronic pancreatic disease
- Participant with history of significant bowel resection that could impair fat absorption
Show all 16Show fewer
- Participant with any condition known to increase fecal fat loss including but not limited to: celiac disease, Crohn's disease, tropical sprue, bacterial bowel infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and pancreatic cancer, radiation enteritis, Whipple's disease, Whipple's procedure, etc
- Participant with any significant gastrointestinal dysmotility disorders
- Participant with chronic abdominal pain or severe abdominal pain at study entry
- Participant using enteral tube feeding over day and night
- Participant with history or presence of clinically significant portal hypertension
- Participant with history or presence of complete distal intestinal obstruction syndrome (DIOS) in the past 6 months, or 2 or more episodes of DIOS in the past year
- Participant with poorly controlled diabetes as per the investigator's opinion
- Female participants who are pregnant or breastfeeding
- Participant with any condition or history of any illness, or pre-study laboratory abnormality which, in the opinion of the investigator or sponsor, might put the participant at risk, prevent the participant from completing the study, or otherwise affect the outcome of the study
- Participant using any investigational drug within 30 days prior to the date of signature of the ICF
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Poland7 sites
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem Poradnia Leczenia Mukowiscydozy
Gdansk
Wojewodzki Specjalistityczny Szpital Dziect Im Sw Ludwika
Krakow
Dziecięcy Szpital Kliniczny im. Prof. Antoniego Gębali
Lublin
Szpital Kliniczny im Karola Jonschera
Poznan
NZOZ Sanatorium Cassia Villa Medica
Rabka-Zdrój
NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii
Rzeszów
Children's Health Memorial Institute
Warsaw
Germany6 sites
Klinikum-Bochum
Bochum
Universitätsklinikum Carl Gustav Carus
Dresden
Universitaetsklinikum Erlangen
Erlangen
Jena University Hospital, Universitaetsklinikum Jena
Jena
Klinikum der Universitat Munchen Medizinische Klinik-Innenstadt
München
University Children's Clinic Tubingen
Tübingen
About this study
Official title: An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
Read the detailed description
This is an open-label, Phase IV, multicenter, randomized, two-period cross-over study to compare the efficacy and safety of Panzytrat® 25,000 to Kreon® 25,000 in participants aged 7 years and older suffering from CF and EPI. The study consists of a qualification phase (5 to 15 days); two treatment periods of 14 days each (plus a 3-day window if needed) and a 3-day stool collection will be performed from Days 12 to 15.
A safety follow-up phone call will be arranged 7-10 days after completion of the treatment phase or after an early discontinuation.
- Conditions
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- Being tested
- Panzytrat® 25,000, Kreon® 25,000
- Keywords
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Steatorrhea, Malabsorption, Malnutrition
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Steatorrhea, Malabsorption Syndromes, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panzytrat® 25,000Drug
Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period.
Kreon® 25,000Drug
Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Panzytrat® 25,000 | Experimental | Not described Receives: Drug: Panzytrat® 25,000 |
| Kreon® 25,000 | Active comparator | Not described Receives: Drug: Kreon® 25,000 |
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)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.
Measured: Day 12 up to Day 15 in first and second treatment periods
Secondary outcomes (13)
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 12 to Day 15 in first and second treatment periods) for total participants was summarized.
Measured: Day 12 up to Day 15 in first and second treatment periods
Percentage of Stools With Normal Consistency
Normal consistency of stool was defined as formed hard, normal or soft stool and abnormal consistency was defined as loose and unformed, liquid stool and diarrhea. Percentage of stools with normal consistency of each participant was calculated as the number of stools with normal consistency relative to the total number of stools during the collection period. Mean percentage of stool with normal consistency during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.
Measured: Day 12 up to Day 15 in first and second treatment periods
Total Weight of Stools
Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods.
Measured: Day 12 up to Day 15 in first and second treatment periods
Mean Weight Per Stool Sample
Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods.
Measured: Day 12 up to Day 15 in first and second treatment periods
Relative Frequency of Days With Abdominal Symptoms
Abdominal symptoms included abdominal pain and flatulence. 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). For each type of abdominal symptom, the relative frequency of days with the symptom for each participant in a treatment period was calculated as the number of days in which the symptom was reported divided by the total number of days in which the abdominal symptom case report form (CRF) was completed. Mean relative frequency of days with abdominal symptoms was calculated during each treatment period (Day 1 to Day 15).
Measured: Day 1 up to Day 15 in first and second treatment periods
Percentage of Participants With Abdominal Distension
Abdominal distension is a sense of increased abdominal pressure by the participant that involves an actual measurable change in the circumference of a participant's abdomen on physical examination. Percentage of participants with abdominal distension was calculated for each treatment period (Day 1 to Day 15).
Measured: Day 1 up to Day 15 in first and second treatment periods
Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)
Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data. Percent CFA was calculated separately for participants who used and did not use acid suppressing therapy (PPIs) during the study.
Measured: Day 12 up to Day 15 in first and second treatment periods
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence regardless of its causal relationship to study drug. A TEAE was defined as any event not present prior to exposure to study drug or any event already present that worsens in either intensity or frequency following exposure to test drug. A SAE was defined as any event that results in death, is immediately life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or is assessed as medically important.
Measured: Baseline up to 30 days after last dose
Nutritional Status as Assessed by Body Weight
Mean body weight was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).
Measured: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Body Mass Index (BMI)
Nutritional status of participants was assessed by determining their BMI. BMI was calculated by dividing body weight (kg) by square of height in meter (m). Mean BMI was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).
Measured: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Electrolytes Level
Nutritional status of participants was assessed by determining their electrolytes (sodium, potassium and chloride) level. Mean electrolytes level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).
Measured: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level
Nutritional status of participants was assessed by determining their albumin, serum transferrin and hemoglobin level. Mean albumin, serum transferrin and hemoglobin level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).
Measured: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Hematocrit Level
Nutritional status of participants was assessed by determining their hematocrit level. Mean hematocrit level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).
Measured: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionMay 2012
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.
- Other trials for Exocrine Pancreatic InsufficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aptalis Medical Information, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327703
- Sponsor's protocol ID
- MA-PA25CF10-01
- Other IDs
- 2010-019267-11
- Status last verified
- Mar 2014
- First submitted
- 28 Mar 2011
- Last updated
- 10 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
- ClinicalTrials.gov ID
- NCT01327703
- Acronym / sponsor ID
- MA-PA25CF10-01
- Conditions
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- Keywords
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Steatorrhea, Malabsorption, Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Posted 10 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
Detailed description
This is an open-label, Phase IV, multicenter, randomized, two-period cross-over study to compare the efficacy and safety of Panzytrat® 25,000 to Kreon® 25,000 in participants aged 7 years and older suffering from CF and EPI. The study consists of a qualification phase (5 to 15 days); two treatment periods of 14 days each (plus a 3-day window if needed) and a 3-day stool collection will be performed from Days 12 to 15.
A safety follow-up phone call will be arranged 7-10 days after completion of the treatment phase or after an early discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panzytrat® 25,000 | Experimental | Drug: Panzytrat® 25,000 |
| Kreon® 25,000 | Active comparator | Drug: Kreon® 25,000 |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Participant or his/her legal representative signed informed consent form (ICF) prior to starting any study procedures
- Participant with clinical diagnosis of CF based on one or more typical clinical features of CF phenotype, in addition to one of the following: a genotype that documents the presence of 2 CF-causing mutation, or a sweat chloride test greater than or equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis on two separate occasions
- Participant with severe EPI confirmed by enzyme-linked immunosorbent assay (ELISA) measurement of fecal elastase-1 (FE-1)
- Male or female participant aged 7 years or older
- Participant currently receiving and has received a stable dose of lipase with either Panzytrat® 25,000 or Kreon® 25,000 for at least 30 days prior to ICF signature
Key exclusion criteria (16 listed)
- Participant with known contraindication, sensitivity or hypersensitivity to Panzytrat® 25,000 or Kreon® 25,000, or to any porcine protein
- Participant who recently received treatment of an emergent acute infection with oral or intravenous (IV) antibiotics that was not stopped at least 14 days prior to randomization
- Participant with chronic use of narcotics that were not stopped at least 7 days prior to the qualification visit
- Participant using of any prohibited medications or products listed in the prohibited medication section of the protocol
- Participant with acute pancreatitis or exacerbation of chronic pancreatic disease
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 |
|---|---|---|
| Panzytrat® 25,000Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period. | Drug | Panzytrat® 25,000 |
| Kreon® 25,000Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period. | Drug | Kreon® 25,000 |
Primary outcome
Percent Coefficient of Fat Absorption (CFA)
Time frame: Day 12 up to Day 15 in first and second treatment periods
Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.
13 secondary outcomes
Mean Daily Number of Stools
Time frame: Day 12 up to Day 15 in first and second treatment periods
Percentage of Stools With Normal Consistency
Time frame: Day 12 up to Day 15 in first and second treatment periods
Total Weight of Stools
Time frame: Day 12 up to Day 15 in first and second treatment periods
Mean Weight Per Stool Sample
Time frame: Day 12 up to Day 15 in first and second treatment periods
Relative Frequency of Days With Abdominal Symptoms
Time frame: Day 1 up to Day 15 in first and second treatment periods
Percentage of Participants With Abdominal Distension
Time frame: Day 1 up to Day 15 in first and second treatment periods
Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)
Time frame: Day 12 up to Day 15 in first and second treatment periods
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after last dose
Nutritional Status as Assessed by Body Weight
Time frame: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Body Mass Index (BMI)
Time frame: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Electrolytes Level
Time frame: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level
Time frame: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Nutritional Status as Assessed by Hematocrit Level
Time frame: Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Panzytrat® 25,000 and Kreon® 25,000 in people with Exocrine Pancreatic Insufficiency and Cystic Fibrosis, run by Forest Laboratories at 13 sites in 2 countries.
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 8 inclusion and 16 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 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland, Germany. 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?
Yes. Results are posted in the registry (first posted 10 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 12 up to Day 15 in first and second treatment periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2014.