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Trial record 1 of 1 for:    D3820C00016
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Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02099591
Recruitment Status : Active, not recruiting
First Posted : March 31, 2014
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development Ltd

Brief Summary:
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.

Condition or disease Intervention/treatment Phase
Constipation, Signs and Symptoms, Digestive Drug: Naloxegol Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids
Actual Study Start Date : November 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxegol

Arm Intervention/treatment
Experimental: Age group: > = 12y to < 18y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Name: Moventig

Experimental: Age group: > = 12y to < 18y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Name: Moventig

Experimental: Age group: > = 6y to < 12y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Name: Moventig

Experimental: Age group: > = 6y to < 12y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Name: Moventig

Experimental: Age group: > = 6mo to < 6y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Name: Moventig

Experimental: Age group: > = 6mo to < 6y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Name: Moventig




Primary Outcome Measures :
  1. To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation [ Time Frame: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours ]

Secondary Outcome Measures :
  1. To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1 [ Time Frame: Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose ]
  2. Palatability of naloxegol liquid drug formulation [ Time Frame: Day 1 and Day 2 after dose ]
  3. Ability of the patient to swallow the tablet [ Time Frame: Day 1 and Day 2 after dose ]
  4. Clinical outcome measures by assessment of laxative use [ Time Frame: From Day 1 until the End of treatment (26 week of study) ]


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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main inclusion criteria, patient with:

  • malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids
  • newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment
  • ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling.

Main exclusion criteria:

  • Current acute or chronic use of methadone
  • History of an neoplasm or an ongoing gastrointestinal-related issue
  • Signs or symptoms of gastrointestinal obstruction
  • History of prolonged neutropenia or thrombocytopenia with clinical sequelae.
  • Patients currently receiving the first cycle of chemotherapy

Information from the National Library of Medicine

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): NCT02099591


Locations
Show Show 17 study locations
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development Ltd
Investigators
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Principal Investigator: Patrick Davies Nottingham Children's Hospital
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Responsible Party: Kyowa Kirin Pharmaceutical Development Ltd
ClinicalTrials.gov Identifier: NCT02099591    
Other Study ID Numbers: D3820C00016
UTN: U1111-1154-5575 ( Other Identifier: World Health Organization )
2013-003935-32 ( EudraCT Number )
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Keywords provided by Kyowa Kirin Pharmaceutical Development Ltd:
Constipation
Colonic Inertia
Dyschezia
Pharmacokinetics
Naloxegol
Paediatric
Opioids
Opioid induced constipation
OIC
Phase 1
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Naloxegol
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents