Trial Outcomes & Findings for To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation (NCT NCT03060512)

Last Updated: 2018-07-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

276 participants

Primary outcome timeframe

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

Results posted on

2018-07-13

Participant Flow

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.

350 subjects were screened and 74 subjects failed to meet the inclusion/exclusion criteria. 276 subjects were randomised to a treatment sequence.

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	137	139
Overall Study Treated With Movantik	136	135
Overall Study Treated With PEG 3350	130	138
Overall Study COMPLETED	130	130
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Adverse Event	4	6
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Non-compliance with study medication	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Movantik, Then PEG 3350 n=132 Participants 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).	PEG 3350, Then Movantik n=138 Participants 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).	Total n=270 Participants Total of all reporting groups
Age, Continuous	55.9 Years STANDARD_DEVIATION 9.38 • n=5 Participants	56.9 Years STANDARD_DEVIATION 9.65 • n=7 Participants	56.4 Years STANDARD_DEVIATION 9.52 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	89 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	49 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=5 Participants	117 Participants n=7 Participants	232 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants	22 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants	113 Participants n=7 Participants	214 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Total (PP Set) n=246 Participants All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.	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).
Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment Prefer Movantik	124 Participants	—
Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment Prefer PEG 3350	118 Participants	—
Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment No preference	4 Participants	—

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Total (PP Set) n=125 Participants All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.	PEG 3350, Then Movantik n=121 Participants 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).
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Strong preference for Movantik	37 Participants	38 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Moderate preference for Movantik	14 Participants	17 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Slight preference for Movantik	11 Participants	7 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence No preference	2 Participants	2 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Slight preference for PEG 3350	9 Participants	8 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Moderate preference for PEG 3350	15 Participants	23 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Strong preference for PEG 3350	37 Participants	26 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Prefer Movantik	62 Participants	62 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Prefer PEG 3350	61 Participants	57 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Preference for Period 1 treatment	62 Participants	57 Participants
Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence Preference for Period 2 treatment	61 Participants	62 Participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Total (PP Set) n=124 Participants All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.	PEG 3350, Then Movantik n=118 Participants 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).
Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 Worked better to relieve my OIC	2.0 Score Interval 0.0 to 3.0	2.0 Score Interval 0.0 to 3.0
Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 Tolerated better	3.0 Score Interval 0.0 to 3.0	3.0 Score Interval 0.0 to 3.0
Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 Was more convenient	3.0 Score Interval 0.0 to 3.0	1.0 Score Interval 0.0 to 3.0
Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 Worked quickly	2.0 Score Interval 0.0 to 3.0	2.0 Score Interval 0.0 to 3.0
Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350 Worked predictably	2.0 Score Interval 0.0 to 3.0	2.0 Score Interval 0.0 to 3.0

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Total (PP Set) n=124 Participants All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.	PEG 3350, Then Movantik n=118 Participants 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).
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Efficacy: No Influence	4 Participants	2 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Efficacy: Mildly Influenced	18 Participants	20 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Efficacy: Moderately Influenced	40 Participants	43 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Efficacy: Strongly Influenced	61 Participants	52 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Tolerability: No Influence	14 Participants	15 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Tolerability: Mildly Influenced	16 Participants	11 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Tolerability: Moderately Influenced	30 Participants	32 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Tolerability: Strongly Influenced	63 Participants	59 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Convenience: No Influence	5 Participants	39 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Convenience: Mildly Influenced	6 Participants	26 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Convenience: Moderately Influenced	26 Participants	17 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Convenience: Strongly Influenced	86 Participants	35 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Quickly: No Influence	15 Participants	14 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Quickly: Mildly Influenced	25 Participants	30 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Quickly: Moderately Influenced	35 Participants	41 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Quickly: Strongly Influenced	48 Participants	32 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Predictably: No Influence	11 Participants	12 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Predictably: Mildly Influenced	21 Participants	15 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Predictably: Moderately Influenced	36 Participants	48 Participants
Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350 Works Predictably: Strongly Influenced	55 Participants	42 Participants

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Total (PP Set) n=267 Participants All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.	PEG 3350, Then Movantik n=267 Participants 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).
Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms	4.5 Score Standard Deviation 1.83	4.5 Score Standard Deviation 1.83

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Total (PP Set) n=267 Participants All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.	PEG 3350, Then Movantik n=267 Participants 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).
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms PGIC Item 1	23 Participants	27 Participants
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms PGIC Item 2	30 Participants	27 Participants
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms PGIC Item 3	21 Participants	20 Participants
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms PGIC Item 4	38 Participants	33 Participants
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms PGIC Item 5	57 Participants	66 Participants
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms PGIC Item 6	61 Participants	65 Participants
PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms PGIC Item 7	32 Participants	28 Participants

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Total (PP Set) n=267 Participants All subjects in the PP Set, including those randomised to both the Movantik/PEG 3350 treatment sequence and the PEG 3350/Movantik treatment sequence.	PEG 3350, Then Movantik n=267 Participants 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).
Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms	-25.0 Score Standard Deviation 31.64	-26.0 Score Standard Deviation 28.82

Adverse Events

Movantik

Serious events: 3 serious events

Other events: 66 other events

Deaths: 0 deaths

PEG 3350

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Movantik n=271 participants at risk The Movantik treatment-emergent safety set included all subjects exposed to at least one dose of Movantik.	PEG 3350 n=268 participants at risk The PEG 3350 treatment-emergent safety set included all subjects exposed to at least one dose of PEG 3350.
Infections and infestations Gastroenteritis	0.37% 1/271 • Number of events 1 • 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.	0.00% 0/268 • 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.
Cardiac disorders Cardiac failure congestive	0.37% 1/271 • Number of events 1 • 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.	0.00% 0/268 • 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.
Gastrointestinal disorders Diarrhoea	0.37% 1/271 • Number of events 1 • 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.	0.00% 0/268 • 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.
Metabolism and nutrition disorders Hypokalaemia	0.37% 1/271 • Number of events 1 • 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.	0.00% 0/268 • 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.
Nervous system disorders Aphasia	0.37% 1/271 • Number of events 1 • 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.	0.00% 0/268 • 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.
Infections and infestations Salmonellosis	0.00% 0/271 • 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.	0.37% 1/268 • Number of events 1 • 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.

Other adverse events

Additional Information

Catherine J. Datto, MD, MS, Movantik Medical Head, USMA

AstraZeneca Pharmaceutical LP

Phone: +1 302 885 1180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER