Clinical trial · Interventional
Asimadoline for the Treatment of Post-Operative Ileus
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Asimadoline on the Duration of POI in Subjects Undergoing Laparoscopic/Hand-Assisted Lap Segmental Colonic Resection Secondary to Colon Cancer, Polypectomy or Diverticulitis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor enrollment (31 of a planned 114 subjects were randomized and evaluable)
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post-Operative Ileus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asimadoline | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Asimadoline 1.0 mg
- description
- Asimadoline 1.0 mg b.i.d.
- interventionNames
- Drug: Asimadoline
- type
- ACTIVE_COMPARATOR
- label
- Asimadoline 3.0 mg
- description
- Asimadoline 3.0 mg b.i.d.
- interventionNames
- Drug: Asimadoline
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females aged 18-80 * Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy * Must sign an ICF * Females of childbearing potential must have a negative pregnancy test at screening Exclusion Criteria: * Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data * Pregnant or breastfeeding females * Use of investigational drugs in previous 30 days * Refusal to discontinue prohibited concomitant medications * Chronic use of prescription narcotics over the previous 6 months
References
Publications (0)
Data not yet available