Phase 4 N=276 Randomized Treatment

To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation

Opioid Induced Constipation

Bottom Line

View on ClinicalTrials.gov: NCT03060512 ↗

Enrolled (actual)

276

Serious AEs

0.7%

Results posted

Jul 2018

Primary outcome: Primary: Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment — 124; 118; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Polyethylene Glycol 3350 (Drug); Movantik (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Aug 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03060512). 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.