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| Name | Class |
|---|---|
| QuintilesIMS, Inc. | UNKNOWN |
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The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Scientific Leadership | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntsville | Alabama | 35801 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26582720 | Result | 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. | |
| 18721170 | 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. |
| Label | URL |
|---|---|
| Movantik\_D3820L00017\_Protocol\_Original-26Jan17\_Redacted\_PDF-A | View source |
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350 subjects were screened and 74 subjects failed to meet the inclusion/exclusion criteria. 276 subjects were randomised to a treatment sequence.
Study was performed in 53 sites in the United States. First subject first visit: 2 March 2017. Last subject completed: 23 August 2017. The entire planned duration of study participation was up to 7 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Movantik, Then PEG 3350 | Subjects received Movantik 25 milligrams (mg) once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Polyethylene Glycol 3350 (PEG 3350) 17 grams (g) of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 2). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2017 | Jul 12, 2018 |
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|
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| 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. |
|
|
| 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36). |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Research Site | Phoenix | Arizona | 85050 | United States |
| Research Site | Phoenix | Arizona | 85051 | United States |
| Research Site | Anaheim | California | 92801 | United States |
| Research Site | Anaheim | California | 92805 | United States |
| Research Site | Lincoln | California | 95648 | United States |
| Research Site | Los Gatos | California | 95032 | United States |
| Research Site | North Hollywood | California | 91606 | United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | San Diego | California | 92114 | United States |
| Research Site | Westminster | California | 92683 | United States |
| Research Site | DeLand | Florida | 32720 | United States |
| Research Site | Fort Myers | Florida | 33912 | United States |
| Research Site | Jacksonville | Florida | 32218 | United States |
| Research Site | Jacksonville | Florida | 32257 | United States |
| Research Site | Jupiter | Florida | 33458 | United States |
| Research Site | Lake City | Florida | 32055 | United States |
| Research Site | Miami | Florida | 33155 | United States |
| Research Site | Miami Springs | Florida | 33166 | United States |
| Research Site | North Miami Beach | Florida | 33162 | United States |
| Research Site | Ormond Beach | Florida | 32174 | United States |
| Research Site | Plantation | Florida | 33317 | United States |
| Research Site | Port Orange | Florida | 32129 | United States |
| Research Site | West Palm Beach | Florida | 33409 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Decatur | Georgia | 30030 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Bloomington | Illinois | 61701 | United States |
| Research Site | Brownsburg | Indiana | 46112 | United States |
| Research Site | Pikesville | Maryland | 21208 | United States |
| Research Site | Waltham | Massachusetts | 02451 | United States |
| Research Site | Troy | Michigan | 48085 | United States |
| Research Site | Wyoming | Michigan | 49519 | United States |
| Research Site | Biloxi | Mississippi | 39531 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Omaha | Nebraska | 68114 | United States |
| Research Site | Las Vegas | Nevada | 89119 | United States |
| Research Site | Trenton | New Jersey | 08611 | United States |
| Research Site | Albuquerque | New Mexico | 87102 | United States |
| Research Site | Endwell | New York | 13760 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Greensboro | North Carolina | 27410 | United States |
| Research Site | High Point | North Carolina | 27262 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Beavercreek | Ohio | 45432 | United States |
| Research Site | Edmond | Oklahoma | 73034 | United States |
| Research Site | Collegeville | Pennsylvania | 19426 | United States |
| Research Site | Levittown | Pennsylvania | 19056 | United States |
| Research Site | Greer | South Carolina | 29651 | United States |
| Research Site | Chattanooga | Tennessee | 37421 | United States |
| Research Site | Kingsport | Tennessee | 37660 | United States |
| Research Site | West Jordan | Utah | 84088 | United States |
| 25164154 | 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. |
| 24896818 | 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. |
| 24904217 | 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. |
| 25802051 | 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. |
| 14739871 | 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. |
| 18924451 | 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. |
| 17955081 | Result | Johanson JF. Review of the treatment options for chronic constipation. MedGenMed. 2007 May 2;9(2):25. |
| 24883055 | 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. |
| 27486340 | 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. |
| 31058652 | Derived | 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. |
| Movantik\_D3820L00017\_SAP\_Redacted\_15Aug2017\_PDF-A | View source |
| FG001 | PEG 3350, Then Movantik | Subjects received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 2). |
| Treated With Movantik |
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| Treated With PEG 3350 |
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| COMPLETED |
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| NOT COMPLETED |
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The baseline population is the Full Analysis Set (FAS) which consisted of all subjects who satisfied the inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Movantik, Then PEG 3350 | Subjects received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 2). |
| BG001 | PEG 3350, Then Movantik | Subjects received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 2). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation. | Posted | Count of Participants | Participants | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). |
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| Primary | 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. | The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important important protocol deviation. | Posted | Count of Participants | Participants | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). |
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| Secondary | 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. | The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation. | Posted | Median | Full Range | Score | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). |
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| Secondary | 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. | The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation. | Posted | Count of Participants | Participants | From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study). |
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| Secondary | 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. | The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods. | Posted | Mean | Standard Deviation | Score | At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2. |
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| Secondary | 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. | The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods. | Posted | Number | Participants | At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2. |
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| 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 | 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. | The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing BFI data at the end of at least one of the two week treatment periods. | Posted | Mean | Standard Deviation | Score | From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36). |
|
Approximately 5 weeks.
The treatment-emergent safety analysis set included all subjects exposed to at least one dose of either study medication and categorised subjects according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Movantik | The Movantik treatment-emergent safety set included all subjects exposed to at least one dose of Movantik. | 0 | 271 | 3 | 271 | 66 | 271 |
| EG001 | PEG 3350 | The PEG 3350 treatment-emergent safety set included all subjects exposed to at least one dose of PEG 3350. | 0 | 268 | 1 | 268 | 46 | 268 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Defaecation urgency | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v20.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v20.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA v20.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Grief reaction | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v20.1 | Systematic Assessment |
|
The Institution and PIs shall be entitled to publish or make presentations related to the Study within 2 years of completion of the Study with Sponsor's prior written consent. PIs shall provide the Sponsor with copies of any materials at least thirty (30) days in advance of publication, submission or presentation.
All such publications or presentations shall be consistent with applicable standards, guidelines and laws, not be false or misleading, and not be made for any commercial purpose.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine J. Datto, MD, MS, Movantik Medical Head, USMA | AstraZeneca Pharmaceutical LP | +1 302 885 1180 | Information.Center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2017 | Jul 12, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| C000589308 | naloxegol |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| OG001 | PEG 3350, Then Movantik | Subjects received PEG 3350 17 g of powder dissolved in 4 to 8 ounces of fluid to be taken once daily for 2 weeks (Treatment Period 1). After a washout period of 1 week, subjects then received Movantik 25 mg once daily on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal for 2 weeks (Treatment Period 2). |
|
|
|
| OG001 | Preferred PEG 3350 | Subjects who preferred PEG 3350 had selected Strong preference for PEG 3350, Moderate preference for PEG 3350 or Slight preference for PEG 3350 during the Patient Preference Assessment at Visit 5. |
|
|
| OG001 | Preferred PEG 3350 | Subjects who preferred PEG 3350 had selected Strong preference for PEG 3350, Moderate preference for PEG 3350 or Slight preference for PEG 3350 during the Patient Preference Assessment at Visit 5. |
|
|
| PEG 3350 FAS |
The PEG 3350 FAS consisted of all subjects who satisfied the inclusion and exclusion criteria, received PEG 3350, and attended at least one scheduled visit. |
|
|
|
| OG001 |
| PEG 3350 FAS |
The PEG 3350 FAS consisted of all subjects who satisfied the inclusion and exclusion criteria, received PEG 3350, and attended at least one scheduled visit. |
|
|
|
|
|