Trial · NCT00443040

Asimadoline for the Treatment of Post-Operative Ileus

NCT00443040, Phase 2, Terminated, Tioga Pharmaceuticals; results first posted 2012-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Asimadoline for the Treatment of Post-Operative Ileus. Trials, record NCT00443040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00443040

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Asimadoline for the Treatment of Post-Operative Ileus
NCT number: NCT00443040
Status: Terminated
Phases: Phase 2
Enrollment: 35 participants, actual
Lead sponsor: Tioga Pharmaceuticals
Conditions: Post-Operative Ileus
Interventions: Asimadoline, Placebo
First posted: 2007-03-05
Last updated: 2012-01-06
Results first posted: 2012-01-06
Limitations and caveats: Early termination leading to small numbers of subjects analyzed; no efficacy analysis was completed.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Return of Upper and Lower GI Function	Daily for 38 days	The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
Secondary	Time to Tolerating Solid Food	4 hours of ingesting a meal	Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal
Secondary	Time to First Passage of Flatus	Daily for 38 days
Secondary	Time to First Bowel Movement	Daily for 38 days
Secondary	Time to Writing of Hospital Discharge Order	Daily for 38 days
Secondary	Nausea Score	Daily for 38 days
Secondary	Vomiting Score	Daily for 38 days
Secondary	Pain Score	Daily for 38 days
Secondary	Nasogastric Tube Re-insertion	Daily for 38 days	Proportion of subjects with nasogastric tube re-insertion
Secondary	Post-operative Analgesic Use	Daily for 38 days

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Time to Tolerating Solid Food	4 hours of ingesting a meal		participants	NUMBER
SECONDARY	Time to First Passage of Flatus	Daily for 38 days		participants	NUMBER
SECONDARY	Time to First Bowel Movement	Daily for 38 days		participants	NUMBER
SECONDARY	Time to Writing of Hospital Discharge Order	Daily for 38 days		participants	NUMBER
SECONDARY	Nausea Score	Daily for 38 days
SECONDARY	Vomiting Score	Daily for 38 days
SECONDARY	Pain Score	Daily for 38 days
PRIMARY	Time to Return of Upper and Lower GI Function	Daily for 38 days	As the study was terminated early due to poor enrollment (31 of a planned 114 subjects were randomized and evaluable), no formal efficacy analyses were conducted.	hours	MEAN
SECONDARY	Nasogastric Tube Re-insertion	Daily for 38 days
SECONDARY	Post-operative Analgesic Use	Daily for 38 days

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Asimadoline 1.0 mg	14
Overall Study	STARTED	Asimadoline 3.0 mg	11
Overall Study	STARTED	Placebo	10
Overall Study	COMPLETED	Asimadoline 1.0 mg	10
Overall Study	COMPLETED	Asimadoline 3.0 mg	11
Overall Study	COMPLETED	Placebo	9
Overall Study	NOT COMPLETED	Asimadoline 1.0 mg	4
Overall Study	NOT COMPLETED	Asimadoline 3.0 mg	0
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events207

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	Nausea	Gastrointestinal disorders	Asimadoline 1.0 mg	5	14	5
other	Nausea	Gastrointestinal disorders	Asimadoline 3.0 mg	7	11	7
other	Nausea	Gastrointestinal disorders	Placebo	4	10	4
other	Procedural Pain	Injury, poisoning and procedural complications	Asimadoline 1.0 mg	4	14	4
other	Procedural Pain	Injury, poisoning and procedural complications	Asimadoline 3.0 mg	5	11	5
other	Procedural Pain	Injury, poisoning and procedural complications	Placebo	6	10	6
other	Abdominal Pain	Gastrointestinal disorders	Asimadoline 1.0 mg	6	14	6
other	Abdominal Pain	Gastrointestinal disorders	Asimadoline 3.0 mg	5	11	5
other	Abdominal Pain	Gastrointestinal disorders	Placebo	3	10	3
other	Vomiting	Gastrointestinal disorders	Asimadoline 1.0 mg	1	14	1

1 to 10 of 207Source ClinicalTrials.gov

See all 207 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Asimadoline 1.0 mg
Total, all-cause mortality	Asimadoline 3.0 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Asimadoline 1.0 mg	14	14
Total, other adverse events	Asimadoline 3.0 mg	11	11
Total, other adverse events	Placebo	10	10
Total, serious adverse events	Asimadoline 1.0 mg	0	14
Total, serious adverse events	Asimadoline 3.0 mg	1	11
Total, serious adverse events	Placebo	1	10

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00443040

GET https://conductscience.org/api/trials/v1/NCT00443040/events?page=2

API reference For AI assistants