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A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Phase 4 trial testing Pancrelipase in Exocrine Pancreatic Insufficiency (EPI) in 1 participant. Terminated before completion.
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 25 February 2020 |
| Primary completion | 23 March 2022 |
| Estimated completion | 23 March 2022 |
| Sites | 33 locations across United States |
AbbVie — full company profile →
21 and older, any sex, with Exocrine Pancreatic Insufficiency (EPI). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Stool samples were collected during the 48 hours prior to the Day 1 and Week 1 visits and analyzed for fat content.
| Group | Value | 95% CI |
|---|---|---|
| Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase | 3.1 |
Participants recorded stool frequency using an electronic diary (eDiary). The average daily stool frequency was calculated from the last 3 days prior to the Baseline and Week 1 visits.
| Group | Value | 95% CI |
|---|---|---|
| Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase | NA |
Participants recorded stool consistency using an electronic diary (eDiary). The change from Baseline to Week 1 is the proportion of days having watery stool consistency in the last 7 days prior to each of Baseline and Week 1 visits. Negative changes from Baseline indicate less frequent watery stools.
| Group | Value | 95% CI |
|---|---|---|
| Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase | -0.29 |
The EPI Symptoms Questionnaire consists of 12 questions. The response scores range from 0 to 4 for each question (0 corresponding to None to 4 corresponding to Very Severe), with the total score ranging from 0 to 48. Positive changes indicate worsening from Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase | 3 |
Time frame: All-cause mortality is reported from enrollment to end of study; time on follow up was 161 days. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; time on study drug was 92 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Resected Participants Rece… | Resected Participants Rece… | Non-Resected Participants … |
|---|---|---|---|---|
| WHITE BLOOD CELLS DECREASED | Investigations | — | — | — |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | — | — | — |
| FATIGUE | General disorders | — | — | — |
| POSTURAL DIZZINESS | Nervous system disorders | — | — | — |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | — | — | — |
Data from ClinicalTrials.gov NCT03859869 adverse events section.
This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.
No peer-reviewed publications indexed yet for this trial.
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