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Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug.
Creon is an approved drug for the treatment of EPI. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States.
Participants will receive oral capsules of CREON for 113 days and will be followed for 30 days.
Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Run-in Period: Creon-ABT | Experimental | Participants will receive Creon-ABT daily for 28 days. |
|
| Treatment Period: Creon-AAPIS | Experimental | Participants will receive Creon-AAPIS daily for 85 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CREON | Drug | Capsule; Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 | The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms. | Day 1 (baseline), 8, 15, 29, and 85 |
| Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 | The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms. | Day 1 (Baseline), 8, 15, 29, and 85 |
| Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 | The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms. | Day 1 (Baseline), 8, 15, 29, and 85 |
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Inclusion Criteria:
Exclusion Criteria:
- Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research /ID# 231076 | Mobile | Alabama | 36608-1771 | United States | ||
| Valley Children's Hospital /ID# 231452 |
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| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
One participant failed continuation criteria, with the remaining 29 participants continuing on to the treatment period with Creon-AAPIS. The Per Protocol Population included all enrolled subjects who received at least 1 dose of Creon-AAPIS, had Day 1 (Baseline) PEI-Q scores collected, and had at least one post-baseline PEI-Q scores collected during the Treatment Period (Days 8, 15, 29, and 85).
Thirty participants were enrolled at 13 sites throughout the United States. During the run-in period, 30 participants were treated and completed 28 days of treatment with Creon-ABT.
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-in: Creon-ABT | Participants received blinded Creon-ABT for the duration of the Run-in Period (28 days) at the same stable individual dose of Creon he/she was on before screening. This assured that the Day 1 assessment reflected the symptoms on stable Creon-ABT use. |
| FG001 | Treatment: Creon-AAPIS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in Period (Day -28 to Day 0) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2021 | Jun 26, 2024 |
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| Madera |
| California |
| 93636 |
| United States |
| University of Florida - Archer /ID# 233411 | Gainesville | Florida | 32610 | United States |
| Atlantic Medical Research /ID# 239568 | Margate | Florida | 33063-5737 | United States |
| University of Miami, Miller School of Medicine /ID# 239415 | Miami | Florida | 33136 | United States |
| GI Pros /ID# 239486 | Naples | Florida | 34102-5449 | United States |
| Central FL Pulmonary Orlando /ID# 245863 | Orlando | Florida | 32803 | United States |
| Asr, Llc /Id# 239566 | Nampa | Idaho | 83687 | United States |
| UMass Chan Medical School /ID# 230476 | Worcester | Massachusetts | 01655 | United States |
| The Curators of the University of Missouri /ID# 233331 | Columbia | Missouri | 65211 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 231633 | Lebanon | New Hampshire | 03756 | United States |
| Albany Medical College-Pulmonary /ID# 250041 | Albany | New York | 12208-3504 | United States |
| NYU Langone Health /ID# 233417 | New York | New York | 10016-2708 | United States |
| Wake Forest Baptist Health /ID# 229537 | Winston-Salem | North Carolina | 27157-0001 | United States |
| University of Cincinnati /ID# 229511 | Cincinnati | Ohio | 45267-0585 | United States |
| UH Cleveland Medical Center /ID# 246065 | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Main Campus /ID# 245864 | Cleveland | Ohio | 44195 | United States |
| Options Health Research, LLC /ID# 239535 | Tulsa | Oklahoma | 74104 | United States |
| Baylor College of Medicine Medical Center /ID# 233441 | Houston | Texas | 77030-4202 | United States |
| Univ Texas HSC San Antonio /ID# 239060 | San Antonio | Texas | 78229-3901 | United States |
| West Virginia University Hospitals /ID# 239593 | Morgantown | West Virginia | 26506 | United States |
Participants who completed the Run-in Period were assessed for the continuation criteria at Day 1. Blinded Creon-ABT study drug from the Run-In Period was returned, and the participant was dispensed blinded Creon-AAPIS to use at the same stable individual dose per LU of Creon he/she was on before Screening and during the Run-in Period. This assured that the treatment assessments after Day 1 reflect the symptoms on Creon-AAPIS. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period (Day 1 to Day 85) |
|
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Full Analysis Set (FAS): The FAS included all enrolled subjects who received at least 1 dose of study drug of Creon-AAPIS. The FAS was used for the summary of participant disposition, demographics, and baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment: Creon-AAPIS | Participants who completed the Run-in Period were assessed for the continuation criteria at Day 1. Blinded Creon-ABT study drug from the Run-In Period was returned, and the participant was dispensed blinded Creon-AAPIS to use at the same stable individual dose per LU of Creon he/she was on before screening and during the Run-in Period. This assured that the treatment assessments after Day 1 reflect the symptoms on Creon-AAPIS. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 | The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms. | The Per Protocol Population included all enrolled subjects who received at least 1 dose of study drug of Creon-AAPIS, had Day 1 (Baseline) PEI-Q scores collected, and had at least one post-baseline PEI-Q scores collected during the Treatment Period (Days 8, 15, 29, and 85). The pharmacodynamic endpoints were analyzed in the Per Protocol Population. Number analyzed indicates the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (baseline), 8, 15, 29, and 85 |
|
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| |||||||||||||||||||||||||||
| Primary | Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 | The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms. | The Per Protocol Population included all enrolled subjects who received at least 1 dose of study drug of Creon-AAPIS, had Day 1 (Baseline) PEI-Q scores collected, and had at least one post-baseline PEI-Q scores collected during the Treatment Period (Days 8, 15, 29, and 85). The pharmacodynamic endpoints were analyzed in the Per Protocol Population. Number analyzed indicates the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (Baseline), 8, 15, 29, and 85 |
| |||||||||||||||||||||||||||||
| Primary | Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85 | The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms. | The Per Protocol Population included all enrolled subjects who received at least 1 dose of study drug of Creon-AAPIS, had Day 1 (Baseline) PEI-Q scores collected, and had at least one post-baseline PEI-Q scores collected during the Treatment Period (Days 8, 15, 29, and 85). The pharmacodynamic endpoints were analyzed in the Per Protocol Population. Number analyzed indicates the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (Baseline), 8, 15, 29, and 85 |
|
All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 28 days for CREON-ABT and 116 days for CREON-AAPIS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in: Creon-ABT | Participants received blinded Creon-ABT for the duration of the Run-in Period (28 days) at the same stable individual dose of Creon he/she was on before screening. This assured that the Day 1 assessment reflected the symptoms on stable Creon-ABT use. | 0 | 30 | 0 | 30 | 1 | 30 |
| EG001 | Treatment: Creon-AAPIS | Participants who completed the Run-in Period were assessed for the continuation criteria at Day 1. Blinded Creon-ABT study drug from the Run-In Period was returned, and the participant was dispensed blinded Creon-AAPIS to use at the same stable individual dose per LU of Creon he/she was on before Screening and during the Run-in Period. This assured that the treatment assessments after Day 1 reflect the symptoms on Creon-AAPIS. | 0 | 29 | 2 | 29 | 9 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2023 | Jun 26, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D050500 | Pancreatitis, Chronic |
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010195 | Pancreatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
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| Change from Baseline to Day 29 |
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| Change from Baseline to Day 85 |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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