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

NCT03060512 | Completed Phase 4 Results FDA Drug

• 1 other identifier: D3820L00017
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 53

Brief 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.

Conditions

Opioid Induced Constipation

Keywords

Opioid Induced constipation,; constipation,; laxative,; bowel movement,; Movantik,; Naloxegol

Outcome Measures

Primary Outcomes (2)

• Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment

  The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set.

  From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

• Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence

  The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Strong preference for PEG 3350, Moderate preference for PEG 3350 and Slight preference for PEG 3350. Preference for Period 1 treatment and Preference for Period 2 treatment included subjects who preferred the first and second treatments respectively taken within a given treatment sequence. The number of subjects in each category is presented per treatment sequence for subjects in the PP Set.

  From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

Secondary Outcomes (5)

• Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350

  From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

• Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350

  From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).

• Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms

  At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.

• PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms

  At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.

• 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

  From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36).

Study Arms (2)

Crossover Group 1

ACTIVE COMPARATOR

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.

Drug: Polyethylene Glycol 3350; Drug: Movantik

Crossover Group 2

ACTIVE COMPARATOR

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.

Drug: Polyethylene Glycol 3350; Drug: Movantik

Interventions

Polyethylene Glycol 3350 DRUG

Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day. Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.

Also known as: MiraLAX

Crossover Group 1; Crossover Group 2

Movantik DRUG

Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal. Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.

Also known as: Naloxegol

Crossover Group 1; Crossover Group 2

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• QuintilesIMS, Inc.: collaborator

Study Sites (53)

Research Site

Huntsville, Alabama, 35801, United States

Location

Research Site

Phoenix, Arizona, 85020, United States

Location

Research Site

Phoenix, Arizona, 85050, United States

Location

Research Site

Phoenix, Arizona, 85051, United States

Location

Research Site

Anaheim, California, 92801, United States

Location

Research Site

Anaheim, California, 92805, United States

Location

Research Site

Lincoln, California, 95648, United States

Location

Research Site

Los Gatos, California, 95032, United States

Location

Research Site

North Hollywood, California, 91606, United States

Location

Research Site

Orange, California, 92868, United States

Location

Research Site

San Diego, California, 92114, United States

Location

Research Site

Westminster, California, 92683, United States

Location

Research Site

DeLand, Florida, 32720, United States

Location

Research Site

Fort Myers, Florida, 33912, United States

Location

Research Site

Jacksonville, Florida, 32218, United States

Location

Research Site

Jacksonville, Florida, 32257, United States

Location

Research Site

Jupiter, Florida, 33458, United States

Location

Research Site

Lake City, Florida, 32055, United States

Location

Research Site

Miami, Florida, 33155, United States

Location

Research Site

Miami Springs, Florida, 33166, United States

Location

Research Site

North Miami Beach, Florida, 33162, United States

Location

Research Site

Ormond Beach, Florida, 32174, United States

Location

Research Site

Plantation, Florida, 33317, United States

Location

Research Site

Port Orange, Florida, 32129, United States

Location

Research Site

West Palm Beach, Florida, 33409, United States

Location

Research Site

Atlanta, Georgia, 30342, United States

Location

Research Site

Decatur, Georgia, 30030, United States

Location

Research Site

Marietta, Georgia, 30060, United States

Location

Research Site

Bloomington, Illinois, 61701, United States

Location

Research Site

Brownsburg, Indiana, 46112, United States

Location

Research Site

Pikesville, Maryland, 21208, United States

Location

Research Site

Waltham, Massachusetts, 02451, United States

Location

Research Site

Troy, Michigan, 48085, United States

Location

Research Site

Wyoming, Michigan, 49519, United States

Location

Research Site

Biloxi, Mississippi, 39531, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Omaha, Nebraska, 68114, United States

Location

Research Site

Las Vegas, Nevada, 89119, United States

Location

Research Site

Trenton, New Jersey, 08611, United States

Location

Research Site

Albuquerque, New Mexico, 87102, United States

Location

Research Site

Endwell, New York, 13760, United States

Location

Research Site

Charlotte, North Carolina, 28204, United States

Location

Research Site

Greensboro, North Carolina, 27410, United States

Location

Research Site

High Point, North Carolina, 27262, United States

Location

Research Site

Winston-Salem, North Carolina, 27103, United States

Location

Research Site

Beavercreek, Ohio, 45432, United States

Location

Research Site

Edmond, Oklahoma, 73034, United States

Location

Research Site

Collegeville, Pennsylvania, 19426, United States

Location

Research Site

Levittown, Pennsylvania, 19056, United States

Location

Research Site

Greer, South Carolina, 29651, United States

Location

Research Site

Chattanooga, Tennessee, 37421, United States

Location

Research Site

Kingsport, Tennessee, 37660, United States

Location

Research Site

West Jordan, Utah, 84088, United States

Location

Related Publications (12)

• Argoff CE, Brennan MJ, Camilleri M, Davies A, Fudin J, Galluzzi KE, Gudin J, Lembo A, Stanos SP, Webster LR. Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation. Pain Med. 2015 Dec;16(12):2324-37. doi: 10.1111/pme.12937. Epub 2015 Nov 19.

  PMID: 26582720 RESULT

• Bell TJ, Panchal SJ, Miaskowski C, Bolge SC, Milanova T, Williamson R. The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1). Pain Med. 2009 Jan;10(1):35-42. doi: 10.1111/j.1526-4637.2008.00495.x. Epub 2008 Aug 18.

  PMID: 18721170 RESULT

• Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014 Oct;26(10):1386-95. doi: 10.1111/nmo.12417. Epub 2014 Aug 28.

  PMID: 25164154 RESULT

• Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.

  PMID: 24896818 RESULT

• Coyne KS, LoCasale RJ, Datto CJ, Sexton CC, Yeomans K, Tack J. 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. Clinicoecon Outcomes Res. 2014 May 23;6:269-81. doi: 10.2147/CEOR.S61602. eCollection 2014.

  PMID: 24904217 RESULT

• Coyne KS, Margolis MK, Yeomans K, King FR, Chavoshi S, Payne KA, LoCasale RJ. Opioid-Induced Constipation Among Patients with Chronic Noncancer Pain in the United States, Canada, Germany, and the United Kingdom: Laxative Use, Response, and Symptom Burden Over Time. Pain Med. 2015 Aug;16(8):1551-65. doi: 10.1111/pme.12724. Epub 2015 Mar 20.

  PMID: 25802051 RESULT

• Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.

  PMID: 14739871 RESULT

• Holzer P. New approaches to the treatment of opioid-induced constipation. Eur Rev Med Pharmacol Sci. 2008 Aug;12 Suppl 1(0 1):119-27.

  PMID: 18924451 RESULT

• Johanson JF. Review of the treatment options for chronic constipation. MedGenMed. 2007 May 2;9(2):25.

  PMID: 17955081 RESULT

• Kumar L, Barker C, Emmanuel A. Opioid-induced constipation: pathophysiology, clinical consequences, and management. Gastroenterol Res Pract. 2014;2014:141737. doi: 10.1155/2014/141737. Epub 2014 May 5.

  PMID: 24883055 RESULT

• McGraw T. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial. Clin Exp Gastroenterol. 2016 Jul 15;9:173-80. doi: 10.2147/CEG.S111693. eCollection 2016.

  PMID: 27486340 RESULT

• Brenner DM, Hu Y, Datto C, Creanga D, Camilleri M. A Randomized, Multicenter, Prospective, Crossover, Open-Label Study of Factors Associated With Patient Preferences for Naloxegol or PEG 3350 for Opioid-Induced Constipation. Am J Gastroenterol. 2019 Jun;114(6):954-963. doi: 10.14309/ajg.0000000000000229.

  PMID: 31058652 DERIVED

Related Links

• Movantik\_D3820L00017\_Protocol\_Original-26Jan17\_Redacted\_PDF-A
• Movantik\_D3820L00017\_SAP\_Redacted\_15Aug2017\_PDF-A

MeSH Terms

Conditions

Opioid-Induced Constipation; Constipation

Interventions

polyethylene glycol 3350; naloxegol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Catherine J. Datto, MD, MS, Movantik Medical Head, USMA
• Organization: AstraZeneca Pharmaceutical LP

Information.Center@astrazeneca.com

+1 302 885 1180

Study Officials

• AstraZeneca Scientific Leadership

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: March 2, 2017
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: July 13, 2018
• Results First Posted: July 13, 2018

Record last verified: 2018-07

Locations

US (53)