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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Opioid Induced Constipation

Treatments: Drug: Movantik; Drug: Polyethylene Glycol 3350

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03060512

D3820L00017

Details and patient eligibility

About

The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.

Full description

This study is a prospective, randomized, open-label crossover study consisting of a 1-week washout period, a 2-week treatment period, another 1-week washout and a final 2-week treatment period. The study will assess the overall patient preference Movantik versus Polyethylene Glycol 3350 for the treatment of their opioid-induced constipation. This study will also evaluate the reasons for patient preference (only among subjects who indicate a preference), patient global impression of change, and change in bowel function over the treatment periods measured by Bowel Function Index. Patient's bowel movement diary will also be collected during the study.

Enrollment: 276 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female between the ages of ≥18 and <85 years

• Self-reported active symptoms of OIC (Opioid Induced Constipation) based on components of the Rome IV criteria at screening. Patients should have at least 2 of the following:

  • <3 SBMs (Spontaneous Bowel Movements) per week
  • Straining >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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Crossover Group 1

Active Comparator group

Description:

Crossover Group Movantik to Polyethylene Glycol 3350 2-period, 2-treatment cross-over model: Subjects will be randomized to Movantik during Treatment period 1 (2 weeks), then crossed over to receive Polyethylene Glycol 3350 for Treatment period 2 (2 weeks) after 1 week washout.

Treatment:

Drug: Polyethylene Glycol 3350

Drug: Movantik

Crossover Group 2

Active Comparator group

Description:

Crossover group Polyethylene Glycol 3350 to Movantik 2-period, 2-treatment cross-over model: Subjects will be randomized to Polyethylene Glycol 3350 during Treatment period 1 (2 weeks), then crossed over to receive Movantik for Treatment period 2 (2 weeks) after 1 week washout.

Treatment:

Drug: Polyethylene Glycol 3350

Drug: Movantik