Trial Outcomes & Findings for A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection (NCT NCT04355169)
NCT ID: NCT04355169
Last Updated: 2022-01-18
Results Overview
TERMINATED
PHASE2
2 participants
Up to 10 days After Surgery
2022-01-18
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Naldemedine 2.5 mg
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 10 days After SurgeryPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 days After SurgeryPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 days After SurgeryPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 3 After SurgeryPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 3 After SurgeryPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the Discharge Date (Days 1-10) up to 30 Days After DischargePopulation: 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.
Outcome measures
Outcome data not reported
Adverse Events
Naldemedine 1.25 mg
Naldemedine 2.5 mg
Naldemedine 5 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogi Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER