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This study was terminated before the planned sample size was enrolled due to very slow enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naldemedine | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2) | Up to 10 days After Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time From the End of Surgery to Time When the Discharge Order is Written | Up to 10 days After Surgery | |
| Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube | Up to 10 days After Surgery |
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Inclusion Criteria:
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).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States | ||
| Norton Hospital |
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This study was terminated by the Sponsor. The Sponsor terminated the study based on the assessment that an adequate number of study sites were not able to reach the planned enrollment. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
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| ID | Title | Description |
|---|---|---|
| FG000 | Naldemedine 1.25 mg | Participants received 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. |
| FG001 | Naldemedine 2.5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2020 | Dec 17, 2021 |
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| Placebo | Drug | Oral tablet |
|
| Percentage of Participants With Nausea on Days 1 Through 3 | Days 1 to 3 After Surgery |
| Percentage of Participants With Vomiting on Days 1 Through 3 | 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 | From the Discharge Date (Days 1-10) up to 30 Days After Discharge |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| University of Louisville Division of Surgery | Louisville | Kentucky | 40208 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| CHRISTUS Mother Frances Hospital - Tyler | Tyler | Texas | 75701 | United States |
| CHRISTUS Trinity Clinic Research | Tyler | Texas | 75702 | United States |
| CHRISTUS Trinity Clinic Surgical Oncology | Tyler | Texas | 75702 | United States |
Participants received 2.5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.
| FG002 | Naldemedine 5 mg | Participants received 5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. |
| FG003 | Placebo | Participants received matching placebo BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery. |
| COMPLETED |
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| NOT COMPLETED |
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This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Naldemedine 1.25 mg | Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. |
| BG001 | Naldemedine 2.5 mg | Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. |
| BG002 | Naldemedine 5 mg | Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. |
| BG003 | Placebo | Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years | ||||||||||||||||||||||||||||||
| Sex: Female, Male |
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| Ethnicity (NIH/OMB) |
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| Race (NIH/OMB) |
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| 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 | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2) | This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported. | Posted | Up to 10 days After Surgery |
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| |||||||||||||||||||||||||||||
| Secondary | Time From the End of Surgery to Time When the Discharge Order is Written | This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported. | Posted | Up to 10 days After Surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube | This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported. | Posted | Up to 10 days After Surgery |
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| Secondary | Percentage of Participants With Nausea on Days 1 Through 3 | This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported. | Posted | Days 1 to 3 After Surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Vomiting on Days 1 Through 3 | This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported. | Posted | Days 1 to 3 After Surgery |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital | This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported. | Posted | From the Discharge Date (Days 1-10) up to 30 Days After Discharge |
|
This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
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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 | Naldemedine 1.25 mg | Participants received 1.25 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Naldemedine 2.5 mg | Participants received 2.5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Naldemedine 5 mg | Participants received 5 mg naldemedine BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Placebo | Participants received matching placebo BID beginning on the day of surgery and for up to a maximum of 10 days post-surgery. | 0 | 0 | 0 | 0 | 0 | 0 |
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This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
The sponsor can embargo results from a PIs center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication.Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 45 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi Inc. | 800-849-9707 | shionogiclintrials-admin@shionogi.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2020 | Dec 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000620491 | naldemedine |
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