Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Constipation

Cancer Pain

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

Methylnaltrexone

Narcotics

methylnaltrexone

placebo

Jeff Cohn

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

Progenics Pharmaceuticals, Inc.

Bausch Health Americas, Inc.

Nervous System Diseases

Neurologic Manifestations

Naloxone

Naloxegol

Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone

Andrew Davies, MD

Jan Tack, MD

This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

The objective of this study is to assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.

The primary safety end point is the incidence of adverse events leading to study discontinuation.

The primary efficacy end point is the response rate assessed in the 4 week observation period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.

Bowel Function Index (BFI) score change of ≥12 points

Patient Global Impression of Improvement (PGI-I)

Apices Soluciones S.L.

Kyowa Kirin Pharmaceutical Development Ltd

Quality of Life

Gastrointestinal Agents

Laxatives

Cathartics

28 days of therapy with 25 mg/day of Naloxegol on cancer patients using opioids and suffering for opioids induced constipation not relieved by first-line laxatives.

Enrico Ruggeri, MD

Opioid-Induced Constipation (OIC) is often associated with a compromised quality of life of patients in palliative care (PC) setting. Among the Peripherally-Acting Mu-Opioid Receptor Antagonists, Naloxegol is the most effective to treat OIC and to improve OIC-related aspects of quality of life in patients with non-cancer pain.

This observational study aims to assess the impact of a 4-weeks Naloxegol therapy on the quality of life in advanced cancer patients with OIC assisted by a home PC program.

The study is enrolling cancer patients with OIC (defined according to Rome IV criteria) not relieved by first-line laxatives, starting the therapy with 25 mg/day of Naloxegol. The main parameters evaluated at the beginning of the therapy (T0) and after 28 days (T28) are: Patient Assessment of Constipation Quality-of-Life (PAC-QoL, 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, satisfaction), evaluation of objective (number of weekly evacuations) and subjective constipation (Bowel Function Index, BFI, normal score\<30), pain assessment by NRS.

Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol

A Multicenter, Observational Prospective Study on Quality of Life (QOL) in Advanced Cancer Patients With Opioid-induced Constipation (OIC) Treated at Home With Naloxegol According to the Clinical Practice

Change of quality of life evaluated by Patient Assessment of Constipation Quality-of-Life (PAC-QoL) at T0 and T28. Each item of the 28-item questionnaire was scored on a 5-point Likert-type scale from 0 to 4, with (0 = none/not at all, 1 = a little bit/a little bit of the time, 2 = moderately/some of the time, 3 = quite a bit/most of the time, 4 = extremely/all the time). Scores were reported overall and for each of the four subscales (physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction). An improvement (reduction) of ≥1 point in PAC-QOL score was considered clinically significant based on previous validation studies.

Change of objective constipation evaluated by number of weekly evacuations.

Change of subjective constipation evaluated by Bowel Function Index (BFI). The BFI is a physician-administered, patient-assessment scale made up of three items: (1) ease of defecation, (2) feeling of incomplete bowel evacuation, and (3) personal judgement of constipation during the last 7 days. The physician asks the patient to rate his or her impression of each of the three items during the previous week on a scale from 0 to 100, with 0 signifying 'not at all' and 100 signifying 'very strong'. The score is then calculated as the average of the three components of the scale with each component being weighted equally. The BFI total score remains on a scale of 0 to 100 with higher scores indicating greater constipation.

Change of pain assessed by Numeric Rating Scale (NRS). The NRS is a 11-points numeric scale through participants were asked to rate their average pain intensity by selecting a single number from 0 to 10. Higher scores indicate a more severe pain.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects	NCT00858754	Opioid-Induced ...	methylnaltrexon... placebo	18 Years - 90 Years	Bausch Health Americas, Inc.
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.	NCT03638440	Opioid Induced ...	Naloxegol	18 Years -	Kyowa Kirin Pharmaceutical Development Ltd
Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol	NCT04294550	Opioid Use Constipation Dr... Cancer	Naloxegol	18 Years -	Fondazione ANT Italia ONLUS
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.	NCT03638440	Opioid Induced ...	Naloxegol	18 Years -	Kyowa Kirin Pharmaceutical Development Ltd
Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol	NCT04294550	Opioid Use Constipation Dr... Cancer	Naloxegol	18 Years -	Fondazione ANT Italia ONLUS
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.	NCT03638440	Opioid Induced ...	Naloxegol	18 Years -	Kyowa Kirin Pharmaceutical Development Ltd

Spots Global Cancer Trial Database for opioid induced constipation