Trial · NCT03521232
A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
NCT03521232, Phase 1, Phase 2, Terminated, Entero Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis. Trials, record NCT03521232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03521232
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
- NCT number
- NCT03521232
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Entero Therapeutics
- Conditions
- Ulcerative Colitis, Ulcerative Proctitis, Ulcerative Proctosigmoiditis
- Interventions
- Niclosamide
- First posted
- 2018-05-11
- Last updated
- 2022-11-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of Niclosamide enemas 150 mg/60 ml and 450 mg/60 ml graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. | baseline to 6 weeks | 1. Number of subjects with serious adverse reactions (i.e. treatment-related) during 6 weeks of treatment with Niclosamide enemas; 2. Number of subjects with grade ≥ 3 adverse reactions during 6 weeks of treatment with Niclosamide enemas; 3. Number of subjects with grade ≥ 2 adverse reactions during 6 weeks of treatment with Niclosamide enemas. |
| Secondary | Number of subjects with clinical remission defined as MMS* ≤ 2 with no individual subscore >1 after 6 weeks of treatment | baseline to 6 weeks | |
| Other | Change in signs and symptoms (rectal bleeding and stool frequency) from baseline to 2, 4 and 6 weeks of treatment | from baseline to 2, 4 and 6 weeks | |
| Other | Change in sigmoidoscopic score (mucosal appearance) from baseline to 6 weeks of treatment | baseline to 6 weeks | |
| Other | Change in hs-CRP and fecal calprotectin from baseline to 2, 4 and 6 weeks of treatment | baseline to 2, 4 and 6 weeks | |
| Other | Change in histology (Geboes index) from baseline to 6 weeks of treatment | baseline to 6 weeks | |
| Other | Change in safety laboratory tests from baseline to 6 weeks of treatment | baseline to 6 weeks | the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided |
| Other | Change in 12-lead ECG parameters from baseline to 2, 4 and 6 weeks of treatment | baseline to 2, 4 and 6 weeks of treatment | 1\. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit |
| Other | Change in heart rate from baseline to 2, 4 and 6 weeks of treatment | baseline to 2, 4 and 6 weeks | summarized descriptively by visit and presented as shift tables |
| Other | Change in quality of life (12-item Short-Form) from baseline to 6 weeks of treatment | baseline to 6 weeks |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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/NCT03521232
GET https://conductscience.org/api/trials/v1/NCT03521232/registered