Trial · NCT04046328
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
NCT04046328, Phase 2, Terminated, Pharmascience Inc.; results first posted 2022-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome. Trials, record NCT04046328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04046328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
- NCT number
- NCT04046328
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Pharmascience Inc.
- Conditions
- Short Bowel Syndrome
- Interventions
- Enteric-Coated Cholestyramine (ECC) Capsule, Placebo
- First posted
- 2019-08-06
- Last updated
- 2022-07-19
- Other registries' IDs
- eudract:2018-004419-32
- Results first posted
- 2022-07-19
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed and abbreviated statistical analyses.
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 the Weekly Frequency of Bowel Movements Measured Between Baseline and the Second Week of Treatment | Baseline and Week 2 of treatment (Days 8 to 14, and Days 36 to 42) | Change in the weekly frequency of bowel movements measured between baseline and the second week of treatment. Baseline is defined as the second week of screening for treatment period 1 and second week of washout for treatment period 2. |
| Secondary | Total Number of Bowel Movements for the Whole 2-week Treatment Period | Days 1 to 14 and Days 29 to 42 | |
| Secondary | Mean Daily Stool Form Score According to the BSFS (Bristol Stool Form Scale), Measured During the Second Week of Treatment | Days 8 to 14, and Days 36 to 42 | The BSFS classifies the form of human feces into seven categories (Type 1 to Type 7) based on stool shape and consistency. Types or scores of 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 tending towards diarrhea, and 6 and 7 indicate diarrhea. |
| Secondary | Mean Daily Dose of Loperamide in mg, if Used, During the Second Week of Treatment | Days 8 to 14, and Days 36 to 42 |
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 the Weekly Frequency of Bowel Movements Measured Between Baseline and the Second Week of Treatment | Baseline and Week 2 of treatment (Days 8 to 14, and Days 36 to 42) | Weekly bowel movements | MEAN | |
| SECONDARY | Total Number of Bowel Movements for the Whole 2-week Treatment Period | Days 1 to 14 and Days 29 to 42 | Bowel movements | MEAN | |
| SECONDARY | Mean Daily Stool Form Score According to the BSFS (Bristol Stool Form Scale), Measured During the Second Week of Treatment | Days 8 to 14, and Days 36 to 42 | Score on BSFS scale | MEAN | |
| SECONDARY | Mean Daily Dose of Loperamide in mg, if Used, During the Second Week of Treatment | Days 8 to 14, and Days 36 to 42 | mg | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Weekly Frequency of Bowel Movements Measured Between Baseline and the Second Week of Treatment | Low Dose ECC Regimen | -11.5 | Standard Deviation 11.38 | Weekly bowel movements | |
| Change in the Weekly Frequency of Bowel Movements Measured Between Baseline and the Second Week of Treatment | High Dose ECC Regimen | -13.4 | Standard Deviation 9.73 | Weekly bowel movements | |
| Total Number of Bowel Movements for the Whole 2-week Treatment Period | Low Dose ECC Regimen | 52.5 | Standard Deviation 20.12 | Bowel movements | |
| Total Number of Bowel Movements for the Whole 2-week Treatment Period | High Dose ECC Regimen | 55.1 | Standard Deviation 25.18 | Bowel movements | |
| Mean Daily Stool Form Score According to the BSFS (Bristol Stool Form Scale), Measured During the Second Week of Treatment | Low Dose ECC Regimen | 3.6 | Standard Deviation 1.42 | Score on BSFS scale | |
| Mean Daily Stool Form Score According to the BSFS (Bristol Stool Form Scale), Measured During the Second Week of Treatment | High Dose ECC Regimen | 3.7 | Standard Deviation 1.76 | Score on BSFS scale | |
| Mean Daily Dose of Loperamide in mg, if Used, During the Second Week of Treatment | Low Dose ECC Regimen | 72.9 | Standard Deviation 43.05 | mg | |
| Mean Daily Dose of Loperamide in mg, if Used, During the Second Week of Treatment | High Dose ECC Regimen | 68.9 | Standard Deviation 53.19 | mg |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (14 Days) | STARTED | Low Dose ECC Regimen, Then High Dose ECC Regimen | 6 | |
| First Intervention (14 Days) | STARTED | High Dose ECC Regimen, Then Low Dose ECC Regimen | 7 | |
| First Intervention (14 Days) | COMPLETED | Low Dose ECC Regimen, Then High Dose ECC Regimen | 6 | |
| First Intervention (14 Days) | COMPLETED | High Dose ECC Regimen, Then Low Dose ECC Regimen | 7 | |
| First Intervention (14 Days) | NOT COMPLETED | Low Dose ECC Regimen, Then High Dose ECC Regimen | 0 | |
| First Intervention (14 Days) | NOT COMPLETED | High Dose ECC Regimen, Then Low Dose ECC Regimen | 0 | |
| Washout (14 Days) | STARTED | Low Dose ECC Regimen, Then High Dose ECC Regimen | 6 | |
| Washout (14 Days) | STARTED | High Dose ECC Regimen, Then Low Dose ECC Regimen | 7 | |
| Washout (14 Days) | COMPLETED | Low Dose ECC Regimen, Then High Dose ECC Regimen | 6 | |
| Washout (14 Days) | COMPLETED | High Dose ECC Regimen, Then Low Dose ECC Regimen | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events14
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 | Abdominal pain upper | Gastrointestinal disorders | Low Dose ECC Regimen | 1 | 13 | |
| other | Abdominal pain upper | Gastrointestinal disorders | High Dose ECC Regimen | 1 | 13 | |
| other | Oedema peripheral | General disorders | Low Dose ECC Regimen | 1 | 13 | |
| other | Oedema peripheral | General disorders | High Dose ECC Regimen | 1 | 13 | |
| other | Pulpitis dental | Infections and infestations | Low Dose ECC Regimen | 1 | 13 | |
| other | Pulpitis dental | Infections and infestations | High Dose ECC Regimen | 1 | 13 | |
| other | C-reactive protein increased | Investigations | Low Dose ECC Regimen | 0 | 13 | |
| other | C-reactive protein increased | Investigations | High Dose ECC Regimen | 1 | 13 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Low Dose ECC Regimen | 1 | 13 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | High Dose ECC Regimen | 0 | 13 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose ECC Regimen | 0 | 13 |
| Total, all-cause mortality | High Dose ECC Regimen | 0 | 13 |
| Total, other adverse events | Low Dose ECC Regimen | 3 | 13 |
| Total, other adverse events | High Dose ECC Regimen | 4 | 13 |
| Total, serious adverse events | Low Dose ECC Regimen | 0 | 13 |
| Total, serious adverse events | High Dose ECC Regimen | 0 | 13 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low Dose ECC Regimen vs High Dose ECC Regimen: deaths from any cause | Trial comparisons |
| Low Dose ECC Regimen vs High Dose ECC Regimen: 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/NCT04046328
GET https://conductscience.org/api/trials/v1/NCT04046328/registered