Trial · NCT02985801
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
NCT02985801, Phase 1, Phase 2, Terminated, Massimo Raimondo, M.D.; results first posted 2021-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer. Trials, record NCT02985801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02985801
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
- NCT number
- NCT02985801
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Massimo Raimondo, M.D.
- Conditions
- Pancreatic Insufficiency, Pancreatic Cancer, Pancreatic Enzyme Abnormality
- Interventions
- Pancrelipase, Placebo Oral Capsule
- First posted
- 2016-12-07
- Last updated
- 2021-03-15
- Results first posted
- 2021-03-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Weight | Baseline, 4 weeks, 10 weeks | Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment. |
| Secondary | Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks | Baseline, 4 weeks | Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life). |
| Secondary | Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks | Baseline, 10 weeks | Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life). |
| Secondary | Change in Body Weight Composition | Baseline, 4 weeks, 10 weeks | Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Body Weight | Baseline, 4 weeks, 10 weeks | Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed. | ||
| SECONDARY | Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks | Baseline, 4 weeks | Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed. | ||
| SECONDARY | Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks | Baseline, 10 weeks | Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed. | ||
| SECONDARY | Change in Body Weight Composition | Baseline, 4 weeks, 10 weeks | Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo First, Then Pancrelipase | 8 | |
| Overall Study | STARTED | Pancrelipase First, Then Placebo | 8 | |
| Overall Study | COMPLETED | Placebo First, Then Pancrelipase | 8 | |
| Overall Study | COMPLETED | Pancrelipase First, Then Placebo | 8 | |
| Overall Study | NOT COMPLETED | Placebo First, Then Pancrelipase | 0 | |
| Overall Study | NOT COMPLETED | Pancrelipase First, Then Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, all-cause mortality | Pancrelipase | 0 | 8 |
| Total, other adverse events | Placebo | 0 | 8 |
| Total, other adverse events | Pancrelipase | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Pancrelipase | 0 | 8 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pancrelipase vs Placebo: deaths from any cause | Trial comparisons |
| Pancrelipase vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02985801
GET https://conductscience.org/api/trials/v1/NCT02985801/registered