Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Constipation

Pain

Opioid-Induced Constipation

Signs and Symptoms, Digestive

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Narcotic Antagonists

Analgesics, Opioid

Naloxegol

Narcotics

Naloxegol 25mg tablets once daily for two weeks

Naloxegol 25mg tablets for two weeks, followed by a two week open-label period

Placebo once daily for two weeks, followed by two week open-label period

Placebo

Janet Bull, MD

The purpose of this study is to determine if naloxegol can be used in the treatment of opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of a two week randomized double blind period followed by a two week open-label period.

Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)

A Study to Assess the Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and Opioid-Induced Constipation

Change from baseline in mean daily NRS (Numerical Rating Scale) values will be calculated as the post-baseline value minus the baseline. Baseline NRS is the mean daily NRS values recorded during the Opioid Induced Constipation (OIC) Confirmation period. Numeric Rating Scale is 0-10. 0 is no pain and 10 is worst possible pain. Lower values are a better outcome and higher values are a worse outcome. Post-baseline values were calculated as the mean of NRS scores during visits 2-4.

Change from baseline in mean daily opioid dose will be calculated as the post-baseline value minus the baseline value. Positive changes from baseline indicate there was a need to increase the opioid dose. Baseline daily opioid dose is the mean daily opioid dose recorded during the Opioid Induced Constipation (OIC) Confirmation period.

Changes from Baseline to Visit 3 (approximately Day 15) for all patients will be calculated as the post-baseline test value minus the baseline test value.

Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) QTC interval data will be derived by subtracting the baseline value from the final assessment data.

Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) heart rate data will be derived by subtracting the baseline value from the final assessment data.

Change from Baseline in systolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.

Change from Baseline in diastolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.

Change from Baseline in respiratory rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.

Change from Baseline in pulse rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.

Daily diary data will be used to identify RFBMs. The weekly RFBM frequency within each time period will be calculated as: (Total number of RFBMs during the time period of interest/number of days) x 7. RFBM rate calculated from post baseline period.

Time (in hours) to first post-dose rescue free bowel movement minus first dose date and time.

The Bristol Stool Scale classifies the type of bowel movement on a scale from 1-7, based on the appearance of stool. 1 indicates severe constipation, 2 indicates mild constipation, 3-4 indicate a normal bowel movement, 5 indicates that the patient is lacking dietary fiber, 6 indicates mild diarrhea, and 7 indicates severe diarrhea. A better score would trend toward the middle of the scale (ranges 3-4), while scores at either end of the scale correspond to worse outcomes.

Bristol Stool Scale (BSS) Score calculated by the sum of daily BSS scores divided by the number of bowel movements that occurred from baseline to study completion. Change from Baseline calculated as the Baseline value minus the post-baseline value.

The PAC-SYM is divided into three subscales. Each item is scored 0-4. Items 1-4 measure abdominal symptoms (total subscale range 0-16), items 5-7 measure rectal symptoms (total subscale score 0-12), and items 8-12 measure stool symptoms (total subscale range 0-20). For each subscale, lower scores are better and higher scores are worse.

The total construct score is generated by summing the scores of the subscales. This total score ranges from 0-48, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes.

Change from baseline in mean values calculated as post-baseline value minus baseline value for each scale, and for total. Post-baseline values defined as the mean of day 15 and day 29.

The PAC-QOL is a 28-item questionnaire divided into 4 subscales. Items 1-4 measure physical discomfort (subscale range 0-16), 5-12 measure psychosocial discomfort (range 0-32), 13-23 measure worries/concerns (range 0-44), and 24-28 measure satisfaction (range 0-20). For each subscale, lower scores are better and higher scores are worse.

The total score is generated by summing the scores of the subscales. This total score ranges from 0-112, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes.

Change from baseline in mean values calculated as post-baseline value minus baseline value for each subscale, and for total. Post-baseline values defined as the mean of day 15 and day 29.

Degree of straining scale is 1 to 5 with 1 being "not at all" and 5 being "an extreme amount". Lower scores are better and higher scores are worse.

Change from baseline in mean values calculated as the post baseline value minus the baseline. Degree of Straining scale change from baseline mean scores calculated from baseline to study completion.

Change from Baseline in mean values calculated as the post baseline value minus the baseline. The post baseline value is the percentage of days from baseline to study completion with at least one complete bowel evacuation.

AstraZeneca

Hospice of Henderson County, Inc.

Chief Medical Officer

Placebo once daily for two weeks

Placebo: Placebo once daily for two weeks, followed by two week open-label period

Naloxegol 25mg tablets once daily for two weeks

Naloxegol: Naloxegol 25mg tablets for two weeks, followed by a two week open-label period

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Baseline Numerical Rating Scale (NRS) for Pain during the OIC Confirmation Period. Numeric Rating Scale is 0-10. 0 is no pain and 10 is worst possible pain. Lower values are a better outcome and higher values are a worse outcome.

Baseline Numerical Rating Scale (NRS) for Pain

Baseline Electrocardiogram QTC Interval

Baseline Electrocardiogram Heart Rate

Baseline Daily Opioid Use

Baseline Systolic Blood Pressure

Baseline Diastolic Blood Pressure

Baseline Pulse Rate

The Bristol Stool Scale classifies the type of bowel movement on a scale from 1-7, based on the appearance of stool. 1 indicates severe constipation, 2 indicates mild constipation, 3-4 indicate a normal bowel movement, 5 indicates that the patient is lacking dietary fiber, 6 indicates mild diarrhea, and 7 indicates severe diarrhea. A better score would trend toward the middle of the scale (ranges 3-4), while scores at either end of the scale correspond to worse outcomes.

Baseline Bristol Stool Scale score

Baseline Respiratory Rate

Degree of straining scale measures the amount of straining during a bowel movement. The scale is 1 to 5 with 1 being "not at all" and 5 being "an extreme amount". Lower scores are better and higher scores are worse.

Baseline Degree of Straining

Baseline Complete Evacuation with Bowel Movements

Abdominal symptoms

Rectal Symptoms

Stool symptoms

Total Score

The PAC-SYM is divided into three subscales. Each item is scored 0-4. Items 1-4 measure abdominal symptoms (total subscale range 0-16), items 5-7 measure rectal symptoms (total subscale score 0-12), and items 8-12 measure stool symptoms (total subscale range 0-20). For each subscale, lower scores are better and higher scores are worse.

The total construct score is generated by summing the scores of the subscales. This total score ranges from 0-48, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes.

Baseline Patient Assessment of Constipation Symptom Assessments (PAC-SYM)

Physical Discomfort

Psychosocial discomfort

Worries/concerns

Satisfaction

The PAC-QOL is a 28-item questionnaire divided into 4 subscales. Each item is scored 0-4. Items 1-4 measure physical discomfort (total subscale range 0-16), 5-12 measure psychosocial discomfort (range 0-32), 13-23 measure worries/concerns (range 0-44), and 24-28 measure satisfaction (range 0-20). For each subscale, lower scores are better and higher scores are worse.

The total score is generated by summing the scores of the subscales. This total score ranges from 0-112, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes.

Baseline Patient Assessment of Constipation (PAC-QOL)

Due to significant recruitment challenges enrollment was stopped. Only 5 patients were randomized (less than 12% of expected). There was insufficient data to perform the protocol specified analysis.

Numerical Rating Scale (NRS) for Pain Change From Baseline

Daily Opioid Use Change From Baseline

All abnormal lab values were deemed not clinically significant by Investigators. Therefore, changes did not meet the criteria for an adverse event and changes were not collected.

Spots Global Cancer Trial Database for Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial