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poor enrollment (31 of a planned 114 subjects were randomized and evaluable)
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| Name | Class |
|---|---|
| RTI Health Solutions | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Asimadoline 1.0 mg | Active Comparator | Asimadoline 1.0 mg b.i.d. |
|
| Asimadoline 3.0 mg | Active Comparator | Asimadoline 3.0 mg b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asimadoline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily for 38 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 hours of ingesting a meal |
| Time to First Passage of Flatus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Mangel, MD, PhD | CMO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States | ||
| Washington University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asimadoline 1.0 mg | Asimadoline 1.0 mg b.i.d. |
| FG001 | Asimadoline 3.0 mg | Asimadoline 3.0 mg b.i.d. |
| FG002 | Placebo | Matching Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asimadoline 1.0 mg | Asimadoline 1.0 mg b.i.d. |
| BG001 | Asimadoline 3.0 mg | Asimadoline 3.0 mg b.i.d. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Not Posted | Number | participants | 4 hours of ingesting a meal | ||||||||||
| Secondary | Time to First Passage of Flatus | Not Posted | Number | participants | Daily for 38 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asimadoline 1.0 mg | Asimadoline 1.0 mg b.i.d. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding gastric ulcer | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed; no efficacy analysis was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allen Mangel, Chief Medical Officer | Tioga Pharmaceuticals | 919-485-5668 | mangel@tiogapharma.com |
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| ID | Term |
|---|---|
| C092095 | asimadoline |
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|
|
| Placebo | Drug | 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. |
|
| Daily for 38 days |
| Time to First Bowel Movement | Daily for 38 days |
| Time to Writing of Hospital Discharge Order | Daily for 38 days |
| Nausea Score | Daily for 38 days |
| Vomiting Score | Daily for 38 days |
| Pain Score | Daily for 38 days |
| Nasogastric Tube Re-insertion | Proportion of subjects with nasogastric tube re-insertion | Daily for 38 days |
| Post-operative Analgesic Use | Daily for 38 days |
| Adverse Events | Adverse events grouped by body system | Daily for 38 days |
| Laboratory Values | Changes in laboratory values. | Daily for 38 days |
| St Louis |
| Missouri |
| 63110 |
| United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106-5047 | United States |
| Marks Colorectal Surgical Associates | Wynnewood | Pennsylvania | 19096 | United States |
| BG002 |
| Placebo |
Matching Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Time to First Bowel Movement | Not Posted | Number | participants | Daily for 38 days |
| Secondary | Time to Writing of Hospital Discharge Order | Not Posted | Number | participants | Daily for 38 days |
| Secondary | Nausea Score | Not Posted | Daily for 38 days |
| Secondary | Vomiting Score | Not Posted | Daily for 38 days |
| Secondary | Pain Score | Not Posted | Daily for 38 days |
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | hours | Daily for 38 days |
|
|
| Secondary | Nasogastric Tube Re-insertion | Proportion of subjects with nasogastric tube re-insertion | Not Posted | Daily for 38 days |
| Secondary | Post-operative Analgesic Use | Not Posted | Daily for 38 days |
| Secondary | Adverse Events | Adverse events grouped by body system | Not Posted | Daily for 38 days |
| Secondary | Laboratory Values | Changes in laboratory values. | Not Posted | Daily for 38 days |
| 0 |
| 14 |
| 14 |
| 14 |
| EG001 | Asimadoline 3.0 mg | Asimadoline 3.0 mg b.i.d. | 1 | 11 | 11 | 11 |
| EG002 | Placebo | Matching Placebo | 1 | 10 | 10 | 10 |
| omental necrosis | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Potassium Decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Painful defaecation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Intestinal functional disorder | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pneumaturia | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Investigator understands and agrees that the first publication of the results of the Research Study, if any, shall be a multicenter publication of the results from all sites. Institution shall not publish, present, or use any results of the Research Study for any purpose until such Research Study has been completed in its entirety at all sites and until such multi-center study publication has been published or for a period of one year following such completion, whichever occurs first.