Trial · NCT01142128
Viokase 16, Viokase16 Plus Nexium and Nexium Alone
NCT01142128, Phase 1, Terminated, University of Florida; results first posted 2013-02-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Viokase 16, Viokase16 Plus Nexium and Nexium Alone. Trials, record NCT01142128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01142128
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Viokase 16, Viokase16 Plus Nexium and Nexium Alone
- NCT number
- NCT01142128
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Chronic Pancreatitis
- Interventions
- Nexium (esomeprazole magnesium), Placebo to Nexium, Viokase 16 (pancrelipase) + Nexium, Viokase 16 + placebo to Nexium
- First posted
- 2010-06-11
- Last updated
- 2013-02-21
- Results first posted
- 2013-02-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of Abdominal Pain for Participants Taking Nexium Alone. | 4 months | To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain |
| Primary | Reduction of Abdominal Pain for Participants Taking Placebo to Nexium | 4 months | To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain |
| Primary | Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium | 4 months | To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain |
| Primary | Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo. | 4 months | To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain |
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 | Reduction of Abdominal Pain for Participants Taking Nexium Alone. | 4 months | Analysis was not able to be done due to the small sample size. | ||
| PRIMARY | Reduction of Abdominal Pain for Participants Taking Placebo to Nexium | 4 months | Analysis was not able to be done due to the small sample size. | ||
| PRIMARY | Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium | 4 months | Analysis was not able to be done due to the small sample size. | ||
| PRIMARY | Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo. | 4 months | Analysis was not able to be done due to the small sample size. |
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 flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 8 | |
| Overall Study | Nexium Alone | All Participants | 3 | |
| Overall Study | Placebo to Nexium, Alone | All Participants | 3 | |
| Overall Study | Viokase 16 Plus Nexium | All Participants | 2 | |
| Overall Study | Viokase 16 Plus Placebo to Nexium | All Participants | 0 | |
| Overall Study | COMPLETED | All Participants | 4 | |
| Overall Study | NOT COMPLETED | All Participants | 4 |
Source ClinicalTrials.gov
Adverse events8
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 | Elevated Liver Enzymes | Hepatobiliary disorders | Nexium Alone | 1 | 3 | 1 |
| other | Elevated Liver Enzymes | Hepatobiliary disorders | Placebo to Nexium, Alone | 0 | 3 | 0 |
| other | Elevated Liver Enzymes | Hepatobiliary disorders | Viokase 16 Plus Nexium | 0 | 2 | 0 |
| other | Elevated Liver Enzymes | Hepatobiliary disorders | Viokase 16 Plus Placebo to Nexium | 0 | 0 | 0 |
| serious | GI Pain | Gastrointestinal disorders | Nexium Alone | 0 | 3 | 0 |
| serious | GI Pain | Gastrointestinal disorders | Placebo to Nexium, Alone | 1 | 3 | 1 |
| serious | GI Pain | Gastrointestinal disorders | Viokase 16 Plus Nexium | 0 | 2 | 0 |
| serious | GI Pain | Gastrointestinal disorders | Viokase 16 Plus Placebo to Nexium | 0 | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nexium Alone | ||
| Total, all-cause mortality | Placebo to Nexium, Alone | ||
| Total, all-cause mortality | Viokase 16 Plus Nexium | ||
| Total, all-cause mortality | Viokase 16 Plus Placebo to Nexium | ||
| Total, other adverse events | Nexium Alone | 1 | 3 |
| Total, other adverse events | Placebo to Nexium, Alone | 0 | 3 |
| Total, other adverse events | Viokase 16 Plus Nexium | 0 | 2 |
| Total, other adverse events | Viokase 16 Plus Placebo to Nexium | 0 | 0 |
| Total, serious adverse events | Nexium Alone | 0 | 3 |
| Total, serious adverse events | Placebo to Nexium, Alone | 1 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01142128
GET https://conductscience.org/api/trials/v1/NCT01142128/registered