A Phase 2/3 interventional study of Naloxegol 25 MG and Placebo pill in Constipation and Constipation Drug Induced, sponsored by TriHealth Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by TriHealth Inc. · Phase 2/3, Interventional, and Treatment
Among 12 studies testing naloxegol in Opioid-Induced Constipation — none open to participants now, none under way, none of them phase 3. naloxegol · Opioid-Induced Constipation.
Among the 12 studies testing naloxegol in Opioid-Induced Constipation, this one is the 6th largest by planned enrollment, is one of 2 that started in 2017, is the only one in phase 2/3, and was the 10th registered.
87 studies on the registry are indexed under Opioid-Induced Constipation; 6 are open to participants now.
This study's planned enrollment of 280 is above the median of 119 across 68 interventional studies indexed under Opioid-Induced Constipation.
Browse Opioid-Induced Constipation studies →None of the 12 studies testing naloxegol in Opioid-Induced Constipation is open now.
naloxegol: first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 5 Opioid-Induced Constipation studies recruiting now, 3 (60%) set no upper age limit and 2 (40%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2017.
Median enrollment 278 across the 12 interventional studies. Of the 11 that completed or were terminated, 7 (64%) have results posted.
9 of 12 have an industry lead sponsor. The 5 most frequent:
TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
TriHealth Inc. has 1 study filed under Opioid-Induced Constipation — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing naloxegol in Opioid-Induced Constipation, from their registry updates:
Nothing recorded among them since 2026-09-25.
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.
87 studies on the registry are indexed under Opioid-Induced Constipation; 6 are open to participants now.
This study's planned enrollment of 280 is above the median of 119 across 68 interventional studies indexed under Opioid-Induced Constipation.
Browse Opioid-Induced Constipation studies →TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Compared within Opioid-Induced Constipation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Constipation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
naloxegol 25 mg pill
Drug: Naloxegol 25 MG
placebo pill
Other: Placebo pill
Naloxegol 25 mg administered 1 hour pre-operatively
Also known as: Movantik
Placebo pill administered 1 hour pre-operatively
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time frame: Post-operative day 1
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time frame: Post-operative day 2
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time frame: Post-operative day 3
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time frame: Post-operative day 4
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time frame: Post-operative day 5
Rescue medications
Amount of rescue medications
Time frame: Post-operative day 1
Rescue medications
Amount of rescue medications
Time frame: Post-operative day 2
Rescue medications
Amount of rescue medications
Time frame: Post-operative day 3
Rescue medications
Amount of rescue medications
Time frame: Post-operative day 4
Rescue medications
Amount of rescue medications
Time frame: Post-operative day 5
Length of stay
CVICU length of stay
Time frame: Post-operative day 1
Length of stay
CVICU length of stay
Time frame: Post-operative day 2
Length of stay
CVICU length of stay
Time frame: Post-operative day 3
Length of stay
CVICU length of stay
Time frame: Post-operative day 4
Length of stay
CVICU length of stay
Time frame: Post-operative day 5
Plan to share: No
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naloxegol