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

Primary Purpose

Opioid Induced Constipation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Polyethylene Glycol 3350

Movantik

About this trial

This is an interventional treatment trial for Opioid Induced Constipation focused on measuring Opioid Induced constipation,, constipation,, laxative,, bowel movement,, Movantik,, Naloxegol

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Crossover Group 1

Crossover Group 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the median score for each characteristic is presented for the overall PP Set according to which treatment was preferred. The assessment was only completed by subjects who indicated an overall preference.

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

In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the number of subjects in each characteristic category is presented for the overall PP Set according to which treatment was preferred. The assessment was only completed by subjects who indicated an overall preference.

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

PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The scoring was as follows: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms. Mean score results are presented for each treatment for Visits 3 and 5.

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

PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The subjects selected one of the following PGIC items as their response: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real differences; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms. The number of subjects responding to each PGIC item at Visits 3 and/or 5 is presented for each treatment overall.

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

The BFI is a 3-item questionnaire administered by a study clinician to measure constipation from the subject's perspective (ease of defecation, feeling of complete evacuation, and personal judgment of constipation). For each item the subject was asked to rate their response on a scale from 0 to 100, where 0 indicates the best response (easy/no diffculty) and 100 the worst response (severe difficulty). The total BFI score was calculated as the mean of the 3 item scores. The mean change from baseline in BFI scores at Visits 3 and/or 5 are presented.

Full Information

NCT ID

NCT03060512

First Posted

February 13, 2017

Last Updated

July 12, 2018

Sponsor

AstraZeneca

Collaborators

QuintilesIMS, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03060512

Brief Title

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

Official Title

A Phase IV, Randomized, Multi-Center, Open-Label, Prospective, Crossover Study to Evaluate Patient Preference of Movantik™ Versus Polyethylene Glycol 3350 for Opioid-Induced Constipation (OIC) Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

March 2, 2017 (Actual)

Primary Completion Date

August 23, 2017 (Actual)

Study Completion Date

August 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

QuintilesIMS, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Induced Constipation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crossover Group 1

Arm Type

Active Comparator

Arm Description

Arm Title

Crossover Group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Polyethylene Glycol 3350

Other Intervention Name(s)

MiraLAX

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Movantik

Other Intervention Name(s)

Naloxegol

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the number of subjects in each characteristic category is presented for the overall PP Set according to which treatment was preferred. The assessment was only completed by subjects who indicated an overall preference.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca Scientific Leadership

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85051

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

California

ZIP/Postal Code

95648

Country

United States

Facility Name

Research Site

City

Los Gatos

State/Province

California

ZIP/Postal Code

95032

Country

United States

Facility Name

Research Site

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92114

Country

United States

Facility Name

Research Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Research Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Research Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32218

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32257

Country

United States

Facility Name

Research Site

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

Research Site

City

Lake City

State/Province

Florida

ZIP/Postal Code

32055

Country

United States

Facility Name

Research Site

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Research Site

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162

Country

United States

Facility Name

Research Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Research Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33317

Country

United States

Facility Name

Research Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32129

Country

United States

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Research Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Research Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Research Site

City

Bloomington

State/Province

Illinois

ZIP/Postal Code

61701

Country

United States

Facility Name

Research Site

City

Brownsburg

State/Province

Indiana

ZIP/Postal Code

46112

Country

United States

Facility Name

Research Site

City

Pikesville

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Research Site

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02451

Country

United States

Facility Name

Research Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Research Site

City

Wyoming

State/Province

Michigan

ZIP/Postal Code

49519

Country

United States

Facility Name

Research Site

City

Biloxi

State/Province

Mississippi

ZIP/Postal Code

39531

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Research Site

City

Trenton

State/Province

New Jersey

ZIP/Postal Code

08611

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Research Site

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Research Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27410

Country

United States

Facility Name

Research Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Research Site

City

Beavercreek

State/Province

Ohio

ZIP/Postal Code

45432

Country

United States

Facility Name

Research Site

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Research Site

City

Collegeville

State/Province

Pennsylvania

ZIP/Postal Code

19426

Country

United States

Facility Name

Research Site

City

Levittown

State/Province

Pennsylvania

ZIP/Postal Code

19056

Country

United States

Facility Name

Research Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Research Site

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Research Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26582720

Citation

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.

Results Reference

result

PubMed Identifier

18721170

Citation

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.

Results Reference

result

PubMed Identifier

25164154

Citation

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.

Results Reference

result

PubMed Identifier

24896818

Citation

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.

Results Reference

result

PubMed Identifier

24904217

Citation

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.

Results Reference

result

PubMed Identifier

25802051

Citation

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.

Results Reference

result

PubMed Identifier

14739871

Citation

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.

Results Reference

result

PubMed Identifier

18924451

Citation

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.

Results Reference

result

PubMed Identifier

17955081

Citation

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

Results Reference

result

PubMed Identifier

24883055

Citation

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.

Results Reference

result

PubMed Identifier

27486340

Citation

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.

Results Reference

result

PubMed Identifier

31058652

Citation

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.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14622&filename=Movantik_D3820L00017_Protocol_Original-26Jan2017_Redacted_PDF-A.pdf

Description

Movantik_D3820L00017_Protocol_Original-26Jan17_Redacted_PDF-A

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14622&filename=Movantik_D3820L00017_SAP_Redacted_15Aug2017_PDF-A.pdf

Description

Movantik_D3820L00017_SAP_Redacted_15Aug2017_PDF-A

Learn more about this trial

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

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

Opioid Induced Constipation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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