Phase 4
Completed N=276
To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
Opioid Induced Constipation
Source: ClinicalTrials.gov NCT03060512 ↗
Enrolled (actual)
276
Serious AEs
0.7%
Results posted
Jul 2018
Primary outcomePrimary: Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment — 124; 118; 4 Participants
◆ Published Evidence
Highly cited
505citations · ~30 / year
The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1).
Summary
The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.
Linked Publications (5)
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The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1).
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Naloxegol for opioid-induced constipation in patients with noncancer pain.
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Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation.
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Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation.
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Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany, and the UK: descriptive analysis of baseline patient-reported outcomes and retrospective chart review.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment |
124; 118; 4 | — |
| PRIMARY Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence |
37; 38; 14; 17; 11; 7 | 0.9239 |
| SECONDARY Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 |
2.0; 2.0; 3.0; 3.0; 3.0; 1.0 | — |
| SECONDARY Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 |
4; 2; 18; 20; 40; 43 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms |
4.5; 4.5 | — |
| SECONDARY PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms |
23; 27; 30; 27; 21; 20 | — |
| SECONDARY Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms |
-25.0; -26.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female between the ages of ≥18 and 25% of defecations
- Sensation of incomplete evacuation >25% of defecations
- Lumpy or hard stools >25% of defecations
- Sensation of anorectal obstruction/blockage >25% of defecations
- Confirmed OIC by BFI (Bowel Function Index) ≥30
- Stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies
- Willingness to stop all laxatives and other bowel regimens other than specified rescue medication
Exclusion Criteria
- Pain related to cancer or has a history of cancer within 5 years
- Current constipation or chronic constipation not caused by or related to use of opioids
- History of rectal evacuation disorders, surgery or procedures that can potentially affect pelvic floor function; requirement of using manual maneuvers to facilitate a bowel movement
- Evidence of significant GI structural abnormalities, acute or chronic GI conditions that could post risk to the patient or confound the study results
- Recent surgery that may affect GI motility or increase risk for bowel obstruction or perforation
- Severe hepatic impairment
- Moderate or severe renal impairment
- Condition that may affect the permeability of blood-brain barrier
- Concomitantly using strong or moderate CYP3A4 inhibitors and strong CYP3A4 inducers
- Any other significant and/or progressive medical, surgical, psychiatric, or mental health condition or any significant laboratory findings that could increase the risk of participation in the study or affect the interpretation of study data as determined by the Investigator
Data sourced from ClinicalTrials.gov (NCT03060512) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.