Post-Operative IleusPhase 2NCT00443040
Asimadoline for the Treatment of Post-Operative Ileus
A Phase 2 study testing Asimadoline in people with Post-Operative Ileus, run by Tioga Pharmaceuticals at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-Operative Ileus
- What is being tested?
- Asimadoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2007to Feb 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lahey Clinic
Burlington, Massachusetts, 01805
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5047
Washington University
St Louis, Missouri, 63110
Marks Colorectal Surgical Associates
Wynnewood, Pennsylvania, 19096
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Post-Operative Ileus
- Being tested
- Asimadoline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsimadolineDrug
Also called EMD 61 753, EMR 63 320
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Asimadoline 1.0 mg | Active comparator | Asimadoline 1.0 mg b.i.d. Receives: Drug: Asimadoline |
| Asimadoline 3.0 mg | Active comparator | Asimadoline 3.0 mg b.i.d. Receives: Drug: Asimadoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily for 38 days
Secondary outcomes (11)
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
Measured: 4 hours of ingesting a meal
Time to First Passage of Flatus
Measured: Daily for 38 days
Time to First Bowel Movement
Measured: Daily for 38 days
Time to Writing of Hospital Discharge Order
Measured: Daily for 38 days
Nausea Score
Measured: Daily for 38 days
Vomiting Score
Measured: Daily for 38 days
Pain Score
Measured: Daily for 38 days
Nasogastric Tube Re-insertion
Proportion of subjects with nasogastric tube re-insertion
Measured: Daily for 38 days
Post-operative Analgesic Use
Measured: Daily for 38 days
Adverse Events
Adverse events grouped by body system
Measured: Daily for 38 days
Laboratory Values
Changes in laboratory values.
Measured: Daily for 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: poor enrollment (31 of a planned 114 subjects were randomized and evaluable)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Operative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tioga Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Allen Mangel, MD, PhD, Study chair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443040
- Sponsor's protocol ID
- ASMP2004
- Status last verified
- Nov 2011
- First submitted
- 27 Feb 2007
- Last updated
- 6 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00443040
- Acronym / sponsor ID
- ASMP2004
- Conditions
- Post-Operative Ileus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment (31 of a planned 114 subjects were randomized and evaluable)
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tioga PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Mar 2007 (estimated)
- Results
- Posted 6 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Asimadoline 1.0 mg | Active comparator | Drug: AsimadolineAsimadoline 1.0 mg b.i.d. |
| Asimadoline 3.0 mg | Active comparator | Drug: AsimadolineAsimadoline 3.0 mg b.i.d. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsimadolineAlso: EMD 61 753, EMR 63 320Asimadoline 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. | Drug | Asimadoline 1.0 mg, Asimadoline 3.0 mg |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Time to Return of Upper and Lower GI Function
Time frame: Daily for 38 days
The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
11 secondary outcomes
Time to Tolerating Solid Food
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
Time frame: Daily for 38 days
Post-operative Analgesic Use
Time frame: Daily for 38 days
Adverse Events
Time frame: Daily for 38 days
Laboratory Values
Time frame: Daily for 38 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-Operative Ileus
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen Mangel, MD, PhD study chair
CMO
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asimadoline in people with Post-Operative Ileus, run by Tioga Pharmaceuticals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return of Upper and Lower GI Function (time frame: Daily for 38 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.