Trial · NCT05724069
Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).
NCT05724069, Phase 2, Completed, Alfasigma S.p.A.; results first posted 2025-08-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). Trials, record NCT05724069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05724069
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).
- NCT number
- NCT05724069
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Alfasigma S.p.A.
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Interventions
- Velusetrag 15 mg once daily for 4 weeks., Placebo once daily for 4 weeks.
- First posted
- 2023-02-13
- Last updated
- 2025-08-03
- Results first posted
- 2025-08-03
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Weekly Global Gastrointestinal Symptoms Average Index Score (WGGSAIS). | 4 weeks. The change is derived as the end of treatment period minus the pre-treatment value of the period, for each period. | Mean change in weekly global gastrointestinal symptoms average index score (WGGSAIS) from pretreatment (PRE) to the end of each treatment period (EOT). The weekly global gastrointestinal symptoms average index score is obtained by averaging the scores for each of the 4 symptoms, abdominal pain, bloating, nausea and vomiting, assessed using a subject's e-diary. Each symptom was rated using a recall period of 7 days and a Likert scale with the following categories: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe according to its influence on usual activity. The WGGSAIS thus ranges between 0 and 4 with lower scores representing better health. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Weekly Global Gastrointestinal Symptoms Average Index Score (WGGSAIS). | 4 weeks. The change is derived as the end of treatment period minus the pre-treatment value of the period, for each period. | Modified Full Analysis Set 1 (mFAS1): the set of subjects responder/naïve to 5-HT4 agonist randomized and treated who reported data on the primary endpoint at least once during a velusetrag treatment period and at least once during a placebo treatment period. Arms were not mutually exclusive. | score | 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 |
|---|---|---|---|---|---|
| Mean Change in Weekly Global Gastrointestinal Symptoms Average Index Score (WGGSAIS). | Modified Full Analysis Set 1 Velusetrag | -0.424 | Standard Deviation 0.6926 | score | |
| Mean Change in Weekly Global Gastrointestinal Symptoms Average Index Score (WGGSAIS). | Modified Full Analysis Set 1 Placebo | -0.185 | Standard Deviation 0.6876 | score |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence A | 5 | |
| Overall Study | STARTED | Sequence B | 4 | |
| Overall Study | STARTED | Sequence C | 4 | |
| Overall Study | STARTED | Sequence D | 4 | |
| Overall Study | COMPLETED | Sequence A | 5 | |
| Overall Study | COMPLETED | Sequence B | 4 | |
| Overall Study | COMPLETED | Sequence C | 4 | |
| Overall Study | COMPLETED | Sequence D | 3 | |
| Overall Study | NOT COMPLETED | Sequence A | 0 | |
| Overall Study | NOT COMPLETED | Sequence B | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events76
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 | hypertension | Vascular disorders | Velusetrag 15 mg Once a Day | 1 | 17 | 1 |
| other | hypertension | Vascular disorders | Placebo Once a Day | 1 | 17 | 1 |
| other | Influenza like illness | General disorders | Velusetrag 15 mg Once a Day | 2 | 17 | 3 |
| other | Influenza like illness | General disorders | Placebo Once a Day | 2 | 17 | 2 |
| other | Pyrexia | General disorders | Velusetrag 15 mg Once a Day | 1 | 17 | 1 |
| other | Pyrexia | General disorders | Placebo Once a Day | 1 | 17 | 1 |
| other | Fatigue | General disorders | Velusetrag 15 mg Once a Day | 0 | 17 | 0 |
| other | Fatigue | General disorders | Placebo Once a Day | 1 | 17 | 1 |
| other | Injection site pruritus | General disorders | Velusetrag 15 mg Once a Day | 1 | 17 | 1 |
| other | Injection site pruritus | General disorders | Placebo Once a Day | 0 | 17 | 0 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Velusetrag 15 mg Once a Day | 0 | 17 |
| Total, all-cause mortality | Placebo Once a Day | 0 | 17 |
| Total, other adverse events | Velusetrag 15 mg Once a Day | 7 | 17 |
| Total, other adverse events | Placebo Once a Day | 10 | 17 |
| Total, serious adverse events | Velusetrag 15 mg Once a Day | 0 | 17 |
| Total, serious adverse events | Placebo Once a Day | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41553253 | DERIVED |
Source PubMed
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 |
|---|---|
| Velusetrag 15 mg Once a Day vs Placebo Once a Day: deaths from any cause | Trial comparisons |
| Velusetrag 15 mg Once a Day vs Placebo Once a Day: 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/NCT05724069
GET https://conductscience.org/api/trials/v1/NCT05724069/events?page=2