| Primary | 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. | Per protocol population included all randomized participants who completed both treatment periods and had all bowel movements appropriately collected with no major protocol violations/deviations or other events considered to potentially bias the study evaluations. | Posted | | Least Squares Mean | Standard Error | percent CFA | | Day 12 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00078.27± 1.033
- OG00180.35± 1.033
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect. | Mixed Models Analysis | | 0.4590 | As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity. | Treatment difference | -2.08 | | | 2-Sided | 95 | -7.23 | 4.02 | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%. |
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| Secondary | 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. | Intent-to-treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | stools per day | | Day 12 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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. | ITT population included all randomized participants. Here, 'N' (number of participants analyzed) specify signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of stools | | Day 12 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | Total Weight of Stools | Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods. | ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period. | Posted | | Mean | Standard Deviation | gram | | Day 12 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | Mean Weight Per Stool Sample | Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods. | ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period. | Posted | | Mean | Standard Deviation | gram | | Day 12 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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). | ITT population included all randomized participants. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies the number of participants with at least one report of the symptom at that severity level during a treatment period. | Posted | | Mean | Standard Deviation | days | | Day 1 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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). | ITT population included all randomized participants. Here, 'N' specifies number of participants who had abdominal distension assessment at screening and end of specified treatment. | Posted | | Number | | percentage of participants | | Day 1 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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. | Per protocol population. Here, 'n' specifies number of participants who were evaluable for specific categories for each arm group, respectively. | Posted | | Least Squares Mean | Standard Error | percent CFA | | Day 12 up to Day 15 in first and second treatment periods | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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. | Safety population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) specifies number of participants who were evaluable for this measure. | Posted | | Number | | participants | | Baseline up to 30 days after last dose | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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). | Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | kg | | Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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). | Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation | | | | ID | Title | Description |
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| OG000 | Panzytrat® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. | | OG001 | Kreon® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. |
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| Secondary | 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). | Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively. | Posted | | Mean | Standard Deviation | millimole/L (mmol/L) | | Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation | | | | ID | Title | Description |
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| OG000 | Panzytrat® First, Then Kreon® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day. | | OG001 | Kreon®, First, Then Panzytrat® | |
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| Secondary | 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). | Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively. | Posted | | Mean | Standard Deviation | gram/L (g/L) | | Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation | | | | ID | Title | Description |
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| OG000 | Panzytrat® First, Then Kreon® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day. | | OG001 | Kreon® First, Then Panzytrat® |
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| Secondary | 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). | Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | proportion of hematocrit | | Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation | | | | ID | Title | Description |
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| OG000 | Panzytrat® First, Then Kreon® | Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day. | | OG001 | Kreon® First, Then Panzytrat® | Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day. |
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