Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC. (NACASY)
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ClinicalTrials.gov Identifier: NCT03638440 |
Recruitment Status :
Completed
First Posted : August 20, 2018
Last Update Posted : May 16, 2022
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Condition or disease | Intervention/treatment |
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Opioid Induced Constipation | Drug: Naloxegol |
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.
Study Type : | Observational |
Actual Enrollment : | 183 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation. |
Actual Study Start Date : | August 16, 2018 |
Actual Primary Completion Date : | March 5, 2020 |
Actual Study Completion Date : | March 5, 2020 |

- Drug: Naloxegol
Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxoneOther Name: Moventig
- To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients. [ Time Frame: 4 week treatment period ]Response rate
- Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment [ Time Frame: 4 week observation period ]Bowel Function Index (BFI) score change of ≥12 points
- Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated). [ Time Frame: 4 week observation period ]Bowel Function Index (BFI) score <30
- Time to the first post-dose bowel movement [ Time Frame: 4 week observation period ]Time to first post-dose bowel movement
- Change in stool consistency [ Time Frame: 4 week observation period ]Bristol stool scale (BSS)
- Change in Patient Assessment of Constipation (PAC-QOL) [ Time Frame: 4 week observation period ]Quality of Life Questionnaire
- Incidence of overall adverse events, including SAEs [ Time Frame: 4 week observation period ]Adverse Events, including SAEs
- Analgesic treatment interruptions/dose adjustments [ Time Frame: 4 week observation period ]Dose adjustments
- Naloxegol treatment interruptions/dose adjustments [ Time Frame: 4 week observation period ]Dose adjustments
- Patient satisfaction (PGI-I) [ Time Frame: 4 week observation period ]Patient Global Impression of Improvement (PGI-I)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patient ≥ 18 years old
- Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study
- Patient with opioid-induced constipation
- Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted)
- Signing of the informed consent
Exclusion Criteria:
- Patients with colorectal cancer

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638440
Denmark | |
Aalborg University Hospital | |
Aalborg, Denmark | |
Finland | |
Tampere University Hospital | |
Tampere, Finland | |
France | |
Paul Papin à Angers et site René Gauducheau | |
Nantes, France | |
Germany | |
Lubecker Onkologische | |
Lübeck, Germany | |
Greece | |
Areteion Hospital | |
Athens, Greece | |
Italy | |
AORN dei Colli | |
Napoli, Italy | |
Netherlands | |
Rijnstate hospital | |
Arnhem, Netherlands | |
Spain | |
ICO-Hospitalet | |
Barcelona, Spain | |
Sweden | |
Skane University Hospital | |
Lund, Sweden | |
United Kingdom | |
Royal Surrey County Hospital | |
Guildford, Surrey, United Kingdom |
Principal Investigator: | Andrew Davies, MD | Royal Surrey County Hospital NHS Foundation Trust | |
Principal Investigator: | Jan Tack, MD | University Hospital KU Leuven |
Responsible Party: | Kyowa Kirin Pharmaceutical Development Ltd |
ClinicalTrials.gov Identifier: | NCT03638440 |
Other Study ID Numbers: |
NACASY |
First Posted: | August 20, 2018 Key Record Dates |
Last Update Posted: | May 16, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Opioid Induced Constipation Naloxegol Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA) |
Constipation Cancer Pain Opioid-Induced Constipation Signs and Symptoms, Digestive Pain Neurologic Manifestations Narcotic-Related Disorders Substance-Related Disorders |
Chemically-Induced Disorders Mental Disorders Naloxegol Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |