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The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKTR-118 12.5mg | Experimental |
| |
| NKTR-118 25mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR-118 | Drug | 12.5 mg oral tablet once daily |
| |
| NKTR-118 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Patients Experiencing at Least One Adverse Event (AE) | The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated. | Baseline (Week 0) to end of the follow-up period (Week 14) |
| Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. | Baseline (Week 0) to end of the follow-up period (Week 14) |
| Incidence of Patients Experiencing Severe Adverse Events (SAEs) | The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated. | Baseline (Week 0) to end of the follow-up period (Week 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) | The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28059433 | Background | Webster L, Tummala R, Diva U, Lappalainen J. A 12-week extension study to assess the safety and tolerability of naloxegol in patients with noncancer pain and opioid-induced constipation. J Opioid Manag. 2016 Nov/Dec;12(6):405-419. doi: 10.5055/jom.2016.0360. | |
| 27342744 | Derived | Lawson R, King F, Marsh K, Altincatal A, Cimen A. Impact of Treatment with Naloxegol for Opioid-Induced Constipation on Patients' Health State Utility. Adv Ther. 2016 Aug;33(8):1331-46. doi: 10.1007/s12325-016-0365-y. Epub 2016 Jun 24. |
| Label | URL |
|---|---|
| Clinical\_Study\_Report\_Synopsis\_D3820C00007 | View source |
Not provided
Study D380C00007 is an extension study of D3820C00004. Of the patients randomized in D3820C00004, n=302 continued and enrolled into D380C00007. The study duration was up to 14 weeks, consisting of a 12 week treatment period and a follow-up visit 2 weeks after the last dose of study drug.
This multicenter study was conducted in the United States between 07 July 2011 and 13 September 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NKTR-118 12.5 mg | NKTR-118 12.5 mg QD, oral treatment |
| FG001 | NKTR-118 25 mg | NKTR-118 25 mg QD, oral treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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Not provided
| Drug |
25 mg oral tablet once daily |
|
| Placebo | Drug | Oral tablet intake once daily |
|
| Baseline (prior to treatment) to last on-treatment assessment (up to Week 12) |
| Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) | The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement. | Baseline (prior to treatment) to last on-treatment assessment (up to Week 12) |
| Calera |
| Alabama |
| United States |
| Research Site | Glendale | Arizona | United States |
| Research Site | Mesa | Arizona | United States |
| Research Site | Phoenix | Arizona | United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Hot Springs | Arkansas | United States |
| Research Site | Malvern | Arkansas | United States |
| Research Site | Anaheim | California | United States |
| Research Site | Beverly Hills | California | United States |
| Research Site | Burbank | California | United States |
| Research Site | Garden Grove | California | United States |
| Research Site | Laguana Hills | California | United States |
| Research Site | Laguna Hills | California | United States |
| Research Site | Long Beach | California | United States |
| Research Site | Los Gatos | California | United States |
| Research Site | Montebello | California | United States |
| Research Site | National City | California | United States |
| Research Site | Norwalk | California | United States |
| Research Site | Paramount | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Boynton Beach | Florida | United States |
| Research Site | Brooksville | Florida | United States |
| Research Site | Crystal River | Florida | United States |
| Research Site | DeLand | Florida | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Hialeah | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Jupiter | Florida | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Naples | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Ormond Beach | Florida | United States |
| Research Site | Pembroke Pines | Florida | United States |
| Research Site | Plantation | Florida | United States |
| Research Site | Tamarac | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Venice | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Boise | Idaho | United States |
| Research Site | Bloomington | Illinois | United States |
| Research Site | Rockford | Illinois | United States |
| Research Site | Avon | Indiana | United States |
| Research Site | Evansville | Indiana | United States |
| Reserach Site | Indianapolis | Indiana | United States |
| Research Site | West Des Moines | Iowa | United States |
| Research Site | Pikesville | Maryland | United States |
| Research Site | Brockton | Massachusetts | United States |
| Research Site | Kalamazoo | Michigan | United States |
| Research Site | Biloxi | Mississippi | United States |
| Research Site | Saint Joseph | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Missoula | Montana | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Trenton | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | New York | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Greensboro | North Carolina | United States |
| Research Site | Hickory | North Carolina | United States |
| Research Site | High Point | North Carolina | United States |
| Research Site | Morrisville | North Carolina | United States |
| Research Site | Beavercreek | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Medord | Oregon | United States |
| Research Site | Feasterville | Pennsylvania | United States |
| Research Site | Huntingdon Valley | Pennsylvania | United States |
| Research Site | Levittown | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Yardley | Pennsylvania | United States |
| Research Site | Cumberland | Rhode Island | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Greer | South Carolina | United States |
| Research Site | Orangeburg | South Carolina | United States |
| Research Site | Clarksville | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Doral | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | North Richland Hills | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Broadmeadow | New South Wales | Australia |
| Research Site | Darlinghurst | New South Wales | Australia |
| Research Site | Port Kembla | New South Wales | Australia |
| Research Site | Westmead | New South Wales | Australia |
| Research Site | Greenslopes | Queensland | Australia |
| Research Site | Adelaide | South Australia | Australia |
| Research Site | Fremantle | Western Australia | Australia |
| Research Site | Nedlands | Western Australia | Australia |
| Research Site | Potsdam | BR | Germany |
| Research Site | Hamburg | Free and Hanseatic City of Hamburg | Germany |
| Research Site | Dietzenbach | Hesse | Germany |
| Research Site | Hüttenberg | Hesse | Germany |
| Research Site | Wetzlar | Hesse | Germany |
| Research Site | Celle | Lower Saxony | Germany |
| Research Site | Hanover | Lower Saxony | Germany |
| Research Site | Schwerin | Mecklenburg-Vorpommern | Germany |
| Research Site | Essen | North Rhine-Westphalia | Germany |
| Research Site | Mainz | Rhineland-Palatinate | Germany |
| Research Site | Leipzig | Saxony | Germany |
| Research Site | Kiel | Schleswig-Holstein | Germany |
| Research Site | Berlin | Germany |
| Research Site | Dresden | Germany |
| Research Site | Banská Bystrica | Slovakia |
| Research Site | Bratislava | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Prešov | Slovakia |
| FG002 |
| Placebo |
Placebo QD, oral treatment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 6 patients (1 patient in the NKTR-118 25 mg group, 2 patients in the NKTR-118 12.5 mg group, 3 patients in the placebo group) had been previously randomized within the NKTR-118 program at a different study center and were excluded from the ITT and Safety analysis sets. Baseline characteristics are summarized using the ITT analysis set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NKTR-118 12.5 mg | NKTR-118 12.5 mg QD, oral treatment |
| BG001 | NKTR-118 25 mg | NKTR-118 25 mg QD, oral treatment |
| BG002 | Placebo | Placebo QD, oral treatment |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | Incidence of Patients Experiencing at Least One Adverse Event (AE) | The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated. | The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers. | Posted | Number | Participants | Baseline (Week 0) to end of the follow-up period (Week 14) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) | The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement. | The modified intent-to-treat(ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The N denotes the number of patients with a baseline and last on-treatment value. | Posted | Mean | Standard Deviation | units on a scale | Baseline (prior to treatment) to last on-treatment assessment (up to Week 12) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) | The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement. | The modified intent-to-treat (ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.The N denotes the number of patients with a baseline and last on-treatment value. | Posted | Mean | Standard Deviation | units on a scale | Baseline (prior to treatment) to last on-treatment assessment (up to Week 12) |
| |||||||||||||||||||||||||||||||||
| Primary | Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. | The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers. | Posted | Number | Participants | Baseline (Week 0) to end of the follow-up period (Week 14) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Incidence of Patients Experiencing Severe Adverse Events (SAEs) | The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated. | The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers. | Posted | Number | Participants | Baseline (Week 0) to end of the follow-up period (Week 14) |
|
|
Not provided
Safety population, i.e. patients who received at least one dose of study medication, was used as the At Risk population
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 | NKTR-118 12.5 mg | 6 | 94 | 15 | 94 | |||
| EG001 | NKTR-118 25 mg | 6 | 97 | 27 | 97 | |||
| EG002 | Placebo | 5 | 100 | 11 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION FUNGAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILU RE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| LOCAL SWELLING | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| BLOOD TESTOSTERONE DECREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| FIBROMYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Sostek | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| 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 |
|---|---|
| C000589308 | naloxegol |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Other |
|
Placebo QD, oral treatment |
|
|
NKTR-118 25 mg QD, oral treatment
| OG002 | Placebo | Placebo QD, oral treatment |
|
|
|
|
|