Trial · NCT00559364
Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
NCT00559364, Phase 3, Completed, Forest Laboratories; results first posted 2014-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea. Trials, record NCT00559364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00559364
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
- NCT number
- NCT00559364
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy
- Interventions
- Viokase® 16, Placebo, Proton pump inhibitor (PPI), Omeprazole
- First posted
- 2007-11-16
- Last updated
- 2017-03-16
- Results first posted
- 2014-03-12
- Limitations and caveats
- Results for percentage of stool characteristics per bowel movement and number of days with at least 1 stool of specific characteristic were not reported due to change in planned analysis.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Coefficient of Fat Absorption (CFA) | Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase | Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined in the stools which was collected from Day 1 to Day 4 or Day 5 during the inpatient period of treatment phase. Mean percent (%) CFA was calculated for Day 1 to Day 4 or Day 5 in inpatient period of treatment phase. |
| Secondary | Mean Daily Number of Stools | Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase | Mean daily number of stools of each patient was calculated from frequency of stools by the patient per day. Mean daily number of stools during the collection period (Day 1 to Day 4 or Day 5 in inpatient period of treatment phase) for total patients was summarized. |
| Secondary | Percentage of Stools Categorized as Per Consistency | Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase | Stool consistency was categorized as hard, formed/normal, soft and watery. Percentage of stools of a specific consistency for each patient was calculated as: (total number of stools of specific consistency during the completed days of the inpatient period/ total number of stools during the completed days of the inpatient period)\*100. Mean percentage of stool categorized as per consistency for total patients was summarized. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Coefficient of Fat Absorption (CFA) | Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase | Intent-to-treat (ITT) population included all randomized patients. Missing values at treatment phase were imputed using the median (50th percentile) of all non-missing values within a treatment group. | percent CFA | MEAN |
| SECONDARY | Mean Daily Number of Stools | Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase | ITT population included all randomized patients. | stools per day | MEAN |
| SECONDARY | Percentage of Stools Categorized as Per Consistency | Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase | ITT population included all randomized patients. | percentage of stools | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Coefficient of Fat Absorption (CFA) | Viokase® | 85.52 | Standard Deviation 8.902 | percent CFA | |
| Percent Coefficient of Fat Absorption (CFA) | Placebo | 58.02 | Standard Deviation 24.249 | percent CFA | |
| Mean Daily Number of Stools | Viokase® | 1.93 | Standard Deviation 0.989 | stools per day | |
| Mean Daily Number of Stools | Placebo | 2.33 | Standard Deviation 0.950 | stools per day | |
| Percentage of Stools Categorized as Per Consistency | Viokase® | Hard stools | 5.08 | Standard Deviation 13.61 | percentage of stools |
| Percentage of Stools Categorized as Per Consistency | Placebo | Hard stools | 0.67 | Standard Deviation 2.98 | percentage of stools |
| Percentage of Stools Categorized as Per Consistency | Viokase® | Formed/normal stools | 45.86 | Standard Deviation 33.27 | percentage of stools |
| Percentage of Stools Categorized as Per Consistency | Placebo | Formed/normal stools | 37.23 | Standard Deviation 37.91 | percentage of stools |
| Percentage of Stools Categorized as Per Consistency | Viokase® | Soft stools | 47.80 | Standard Deviation 33.31 | percentage of stools |
| Percentage of Stools Categorized as Per Consistency | Placebo | Soft stools | 55.48 | Standard Deviation 39.46 | percentage of stools |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Viokase® | 30 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | Viokase® | 29 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Viokase® | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Viokase® | 1 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 20 | |
| other | Anal pruritus | Gastrointestinal disorders | Viokase® | 2 | 30 | |
| other | Anal pruritus | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Viokase® | 1 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Ascites | Gastrointestinal disorders | Viokase® | 1 | 30 | |
| other | Ascites | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Flatulence | Gastrointestinal disorders | Viokase® | 1 | 30 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 0 | 20 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Viokase® | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Viokase® | 7 | 30 |
| Total, other adverse events | Placebo | 2 | 20 |
| Total, serious adverse events | Viokase® | 2 | 30 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Viokase® vs Placebo: serious adverse events |
Source 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/NCT00559364
GET https://conductscience.org/api/trials/v1/NCT00559364/events?page=2