Postoperative Gastrointestinal DysfunctionPhase 2NCT04355169
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
A Phase 2 study testing Naldemedine in people with Postoperative Gastrointestinal Dysfunction, run by Shionogi at 8 sites in United States.
Trial summary
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Gastrointestinal Dysfunction
- What is being tested?
- Naldemedine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Nov 2020to 4 Jan 2021
- 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
- Scheduled to undergo 1 of the following procedures via open (nonlaparoscopic) surgery under general anesthesia:
- partial small or large bowel resection with primary anastomosis
- radical cystectomy requiring bowel transection with primary anastomosis
- Planned to be managed postoperatively with an enhanced recovery protocol, which, at a minimum, includes all of the following elements:
- early removal of the nasogastric tube, which is defined as removal of the nasogastric tube at the end of surgery
- early ambulation, which is defined as ambulation on Day 1
Show all 9Show fewer
- early diet advancement on Day 1
- Planned to receive primary postoperative pain management with opioid analgesia administered by any route.
- American Society of Anesthesiologists (ASA) Physical Status Score of I, II, or III (a normal healthy participant, a participant with mild systemic disease, and a participant with systemic disease, respectively).
Who cannot join
- Scheduled to undergo a total colectomy or any procedure that results in a colostomy or ileostomy.
- Scheduled for endoscopic or laparoscopic surgery.
- Complete bowel obstruction.
- Complicated inflammatory bowel disease (such as ulcerative colitis or Crohn's disease).
- More than 2 major abdominal surgery (for example, gastrectomy, gastric bypass, gastric sleeve, lap banding, pancreatic resection, hepatectomy, intestinal transplant).
- More than 3 doses of an opioid (regardless of the route of administration) during the 7 days prior to surgery.
- Pregnancy or lactation.
- Presence of peritoneal catheter (for example, for dialysis or chemotherapy).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Houston Methodist Hospital
Houston, Texas, 77030
Norton Hospital
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
University of Louisville Division of Surgery
Louisville, Kentucky, 40208
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
CHRISTUS Mother Frances Hospital - Tyler
Tyler, Texas, 75701
CHRISTUS Trinity Clinic Research
Tyler, Texas, 75702
CHRISTUS Trinity Clinic Surgical Oncology
Tyler, Texas, 75702
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine in Patients Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
- Being tested
- Naldemedine, Placebo
- Keywords
- Bowel resection, Gastrointestinal recovery, peripherally acting mu-opioid receptor antagonist, Bowel transection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaldemedineDrug
Also called S-297995
Oral tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Naldemedine 1.25 mg | Experimental | Participants will receive 1.25 milligrams (mg) naldemedine twice daily (BID) beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. Receives: Drug: Naldemedine |
| Naldemedine 2.5 mg | Experimental | Participants will receive 2.5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. Receives: Drug: Naldemedine |
| Naldemedine 5 mg | Experimental | Participants will receive 5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. Receives: Drug: Naldemedine |
| Placebo | Placebo comparator | Participants will receive matching placebo BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)
Measured: Up to 10 days After Surgery
Secondary outcomes (5)
Time From the End of Surgery to Time When the Discharge Order is Written
Measured: Up to 10 days After Surgery
Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube
Measured: Up to 10 days After Surgery
Percentage of Participants With Nausea on Days 1 Through 3
Measured: Days 1 to 3 After Surgery
Percentage of Participants With Vomiting on Days 1 Through 3
Measured: Days 1 to 3 After Surgery
Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital
Measured: From the Discharge Date (Days 1-10) up to 30 Days After Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start6 Nov 2020
- Primary completion4 Jan 2021
- Study completion4 Jan 2021
Why it stopped: This study was terminated before the planned sample size was enrolled due to very slow enrollment.
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 Postoperative Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355169
- Sponsor's protocol ID
- 1902G1721
- Status last verified
- Dec 2021
- First submitted
- 17 Apr 2020
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine in Patients Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
- ClinicalTrials.gov ID
- NCT04355169
- Acronym / sponsor ID
- 1902G1721
- Keywords
- Bowel resection, Gastrointestinal recovery, peripherally acting mu-opioid receptor antagonist, Bowel transection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated before the planned sample size was enrolled due to very slow enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Naldemedine 1.25 mg | Experimental | Drug: NaldemedineParticipants will receive 1.25 milligrams (mg) naldemedine twice daily (BID) beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. |
| Naldemedine 2.5 mg | Experimental | Drug: NaldemedineParticipants will receive 2.5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. |
| Naldemedine 5 mg | Experimental | Drug: NaldemedineParticipants will receive 5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Scheduled to undergo 1 of the following procedures via open (nonlaparoscopic) surgery under general anesthesia:
- Planned to be managed postoperatively with an enhanced recovery protocol, which, at a minimum, includes all of the following elements:
- Planned to receive primary postoperative pain management with opioid analgesia administered by any route.
- American Society of Anesthesiologists (ASA) Physical Status Score of I, II, or III (a normal healthy participant, a participant with mild systemic disease, and a participant with systemic disease, respectively).
Key exclusion criteria (8 listed)
- Scheduled to undergo a total colectomy or any procedure that results in a colostomy or ileostomy.
- Scheduled for endoscopic or laparoscopic surgery.
- Complete bowel obstruction.
- Complicated inflammatory bowel disease (such as ulcerative colitis or Crohn's disease).
- More than 2 major abdominal surgery (for example, gastrectomy, gastric bypass, gastric sleeve, lap banding, pancreatic resection, hepatectomy, intestinal transplant).
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 |
|---|---|---|
| NaldemedineAlso: S-297995Oral tablet | Drug | Naldemedine 1.25 mg, Naldemedine 2.5 mg, Naldemedine 5 mg |
| PlaceboOral tablet | Drug | Placebo |
Primary outcome
Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)
Time frame: Up to 10 days After Surgery
5 secondary outcomes
Time From the End of Surgery to Time When the Discharge Order is Written
Time frame: Up to 10 days After Surgery
Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube
Time frame: Up to 10 days After Surgery
Percentage of Participants With Nausea on Days 1 Through 3
Time frame: Days 1 to 3 After Surgery
Percentage of Participants With Vomiting on Days 1 Through 3
Time frame: Days 1 to 3 After Surgery
Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital
Time frame: From the Discharge Date (Days 1-10) up to 30 Days After Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Gastrointestinal Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Different Acupoint Stimulation for Postoperative Gastrointestinal Dysfunction in Primary Liver Cancer Patients
Primary Liver Cancer
Not yet recruiting
Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery
Postoperative Gastric Distension, Postoperative Gastrointestinal Dysfunction
Recruiting
the Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery
Postoperative Gastrointestinal Dysfunction (POGD)
Recruiting
Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Low Anterior Resection Syndrome (LARS), Rectal Neoplasm Malignant
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.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
8 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 Naldemedine in people with Postoperative Gastrointestinal Dysfunction, run by Shionogi at 8 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 9 inclusion and 8 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 18 Jan 2022). 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 From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2) (time frame: Up to 10 days After Surgery). 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 18 Jan 2022.