A Phase 2 interventional study of Asimadoline and Placebo in Post-Operative Ileus, sponsored by Tioga Pharmaceuticals. Terminated at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-01-06.
Sponsored by Tioga Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
This randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of two dose levels of asimadoline on the duration of post-operative ileus in subjects undergoing laparoscopic or hand-assisted laparoscopic colon resections. Subjects meeting entry criteria were randomized in a 1:1:1 ratio to receive either asimadoline 1.0 mg, asimadoline 3.0 mg or a placebo. One hundred and fourteen subjects were planned, and in the event that a subject was converted from a laparoscopic surgery to an open surgery (laparotomy), that subject would be discontinued from the trial and followed for safety only. The protocol allowed subjects converted to open procedures to be replaced. The first dose was administered approximately 90 minutes pre-operatively, and subsequent dosing was b.i.d. for up to 10 post-operative doses. Subjects were dosed with study drug only while in the hospital. After discharge, they were followed for an additional 28 days. Total study duration for each patient was approximately 5 to 6 weeks.
124 studies on the registry are indexed under Ileus; 12 are open to participants now.
This study's enrollment of 35 is below the median of 97 across 106 interventional studies indexed under Ileus.
Browse Ileus studies →Tioga Pharmaceuticals is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Asimadoline 1.0 mg b.i.d.
Drug: Asimadoline
Asimadoline 3.0 mg b.i.d.
Drug: Asimadoline
Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.
Also known as: EMD 61 753, EMR 63 320
Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.
Time to Return of Upper and Lower GI Function
The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
Time frame: Daily for 38 days
Time to Tolerating Solid Food
Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal
Time frame: 4 hours of ingesting a meal
Time to First Passage of Flatus
Time frame: Daily for 38 days
Time to First Bowel Movement
Time frame: Daily for 38 days
Time to Writing of Hospital Discharge Order
Time frame: Daily for 38 days
Nausea Score
Time frame: Daily for 38 days
Vomiting Score
Time frame: Daily for 38 days
Pain Score
Time frame: Daily for 38 days
Nasogastric Tube Re-insertion
Proportion of subjects with nasogastric tube re-insertion
Time frame: Daily for 38 days
Post-operative Analgesic Use
Time frame: Daily for 38 days
Adverse Events
Adverse events grouped by body system
Time frame: Daily for 38 days
Laboratory Values
Changes in laboratory values.
Time frame: Daily for 38 days
| Milestone | Asimadoline 1.0 mg | Asimadoline 3.0 mg | Placebo |
|---|---|---|---|
| Started | 14 | 11 | 10 |
| Completed | 10 | 11 | 9 |
| Not completed | 4 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Converted to an open laparotomy | 3 | 0 | 1 |
Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
No measurements were reported for this outcome.
Proportion of subjects with nasogastric tube re-insertion
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Adverse events grouped by body system
Results for this outcome have not been posted.
Changes in laboratory values.
Results for this outcome have not been posted.
Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asimadoline 1.0 mg | — | 0/14 (0%) | 14/14 (100%) |
| Asimadoline 3.0 mg | — | 1/11 (9.1%) | 11/11 (100%) |
| Placebo | — | 1/10 (10%) | 10/10 (100%) |
| Event | Asimadoline 1.0 mg | Asimadoline 3.0 mg | Placebo |
|---|---|---|---|
| bleeding gastric ulcerGastrointestinal disorders | 0/14 | 0/11 | 1/10 |
| omental necrosisGastrointestinal disorders | 0/14 | 1/11 | 0/10 |
| Event | Asimadoline 1.0 mg | Asimadoline 3.0 mg | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 5/14 | 7/11 | 4/10 |
| Procedural PainInjury, poisoning and procedural complications | 4/14 | 5/11 | 6/10 |
| Abdominal PainGastrointestinal disorders | 6/14 | 5/11 | 3/10 |
| VomitingGastrointestinal disorders | 1/14 | 4/11 | 0/10 |
| Abdominal DistensionGastrointestinal disorders | 4/14 | 1/11 | 0/10 |
| Incision Site PainInjury, poisoning and procedural complications | 3/14 | 0/11 | 1/10 |
| HeadacheNervous system disorders | 2/14 | 2/11 | 1/10 |
| Wound InfectionInfections and infestations | 1/14 | 2/11 | 1/10 |
| AnaemiaBlood and lymphatic system disorders | 0/14 | 2/11 | 0/10 |
| DizzinessNervous system disorders | 0/14 | 2/11 | 0/10 |
| Age, Categorical(Participants) | Asimadoline 1.0 mg | Asimadoline 3.0 mg | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 6 | 6 | 22 |
| >=65 years | 4 | 5 | 4 | 13 |
| Age Continuous(years) | Asimadoline 1.0 mg | Asimadoline 3.0 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 58 ± 9.7 | 60 ± 12.9 | 57 ± 15.3 | 58 ± 12.2 |
| Sex: Female, Male(Participants) | Asimadoline 1.0 mg | Asimadoline 3.0 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 5 | 7 | 3 | 15 |
| Male | 9 | 4 | 7 | 20 |
| Region of Enrollment(participants) | Asimadoline 1.0 mg | Asimadoline 3.0 mg | Placebo | Total |
|---|---|---|---|---|
| United States | 14 | 11 | 10 | 35 |
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Tioga Pharmaceuticals