Trial · NCT00471315
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
NCT00471315, Phase 3, Completed, Medical University of South Carolina; results first posted 2014-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction). Trials, record NCT00471315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00471315
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
- NCT number
- NCT00471315
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Sphincter of Oddi Dysfunction
- Interventions
- Duloxetine
- First posted
- 2007-05-09
- Last updated
- 2014-02-06
- Results first posted
- 2014-02-06
- Limitations and caveats
- Most frequently reported adverse events included fatigue, nausea, headaches, constipation, decreased appetite and insomnia at primarily mild to moderate severity.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale. | 3 months | The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome. |
| Secondary | Toleration of the Medication as Measured by the Duloxetine Compliance Rate | 3 Months | The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Toleration of the Medication as Measured by the Duloxetine Compliance Rate | 3 Months | participants | NUMBER | |
| PRIMARY | The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale. | 3 months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Toleration of the Medication as Measured by the Duloxetine Compliance Rate | Duloxetine | 10 | participants | ||
| The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale. | Duloxetine | 3.3 | Standard Deviation 1.32 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Duloxetine | 18 | |
| Overall Study | COMPLETED | Duloxetine | 10 | |
| Overall Study | NOT COMPLETED | Duloxetine | 8 |
Source ClinicalTrials.gov
Adverse events6
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 | Fatigue | General disorders | Duloxetine | 11 | 18 | 11 |
| other | Nausea | General disorders | Duloxetine | 10 | 18 | 10 |
| other | Headaches | General disorders | Duloxetine | 5 | 18 | 5 |
| other | Constipation | Gastrointestinal disorders | Duloxetine | 4 | 18 | 4 |
| other | Decreased appetite | Gastrointestinal disorders | Duloxetine | 4 | 18 | 4 |
| other | Insomnia | General disorders | Duloxetine | 4 | 18 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Duloxetine | ||
| Total, other adverse events | Duloxetine | 11 | 18 |
| Total, serious adverse events | Duloxetine | 0 | 18 |
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 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/NCT00471315
GET https://conductscience.org/api/trials/v1/NCT00471315/registered