A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2021-01-04

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Gastrointestinal Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Naldemedine 1.25 mg

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.

Group Type EXPERIMENTAL

Naldemedine

Intervention Type DRUG

Oral tablet

Naldemedine 2.5 mg

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.

Group Type EXPERIMENTAL

Naldemedine

Intervention Type DRUG

Oral tablet

Naldemedine 5 mg

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.

Group Type EXPERIMENTAL

Naldemedine

Intervention Type DRUG

Oral tablet

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet

Interventions

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Naldemedine

Oral tablet

Intervention Type DRUG

Placebo

Oral tablet

Intervention Type DRUG

Other Intervention Names

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S-297995

Eligibility Criteria

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Inclusion Criteria

* 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
* 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).

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No