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Trial record 46 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

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ClinicalTrials.gov Identifier: NCT02099591
Recruitment Status : Recruiting
First Posted : March 31, 2014
Last Update Posted : July 11, 2019
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 : 48 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
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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


Contacts
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Contact: Fiona Miller 00 44 1896 668 168 fiona.miller@kyowakirin.com
Contact: Kerry Sandilands 00 44 1896 66 8172 kerry.sandilands@kyowakirin.com

Locations
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Denmark
Rigshospitalet Withdrawn
Copenhagen, Denmark, DK-2100
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Christina Granhøj Nielsen         
Principal Investigator: Niels Qvist         
Israel
Soroka University Medical Center Withdrawn
Beersheva, Israel, 84141
Rambam Medical Center, Oncology Institute Completed
Haifa, Israel, 31096
Schneider Children Medical Center Completed
Petach Tikva, Israel, 49202
Sheba Medical Center, Multiple Sclerosis Center Withdrawn
Ramat- Gan, Israel, 52621
Netherlands
Academisch Medisch Centrum Withdrawn
Amsterdam, Netherlands, 1105 AZ
Erasmus Medisch Centrum Withdrawn
Rotterdam, Netherlands, 3015 CN
Norway
Haukeland Universitetssykehus Recruiting
Bergen, Norway, 5021
Contact: Jorunn Johanne Jacobsen Syltøy         
Principal Investigator: Camilla Tondel         
Oslo University Hospital - Rikshospitalet Recruiting
Oslo, Norway, 0372
Contact: Anne Marie Halstensen         
Principal Investigator: Heidi Glosli         
St. Olavs Hospital Recruiting
Trondheim, Norway, 7006
Contact: Katrine Iversen Skar         
Principal Investigator: Magnus Hjort         
Spain
Hosptial Santa Creu i Sant Pau Withdrawn
Barcelona, Spain, 08035
Pediatric Oncology Unit Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Raquel Hladun         
Principal Investigator: Soledad Gallego Melcon         
Hospital Sant Joan de Deu Withdrawn
Barcelona, Spain, 08950
Hospital Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Ana Vera         
Principal Investigator: Jorge Huerta         
Hosptial Universitario Ramon y Cajal Withdrawn
Madrid, Spain, 28034
Hospital Infantil Universitario Nino Jesus Completed
Madrid, Spain, 28046
Hospital Universitario Madrid Sanchinarro Not yet recruiting
Madrid, Spain, 28050
Contact: Paola Hernandez         
Principal Investigator: Blanca Lopez Ibor         
Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe Recruiting
Madrid, Spain, 28660
Contact: Sonia García Calvo         
Principal Investigator: Bianca Lopez-Ibor         
Hospital Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain, 03191
Contact: Susana Reyes         
Principal Investigator: Susana Reyes         
United Kingdom
The Leeds Teaching Hosptial NHS Trust Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Sarah Hanson         
Principal Investigator: Susan Picton         
Alder Hey Children's Hospital Completed
Liverpool, United Kingdom, L12 2AP
Royal Marsden Hospital Completed
London, United Kingdom, SW3 6JJ
Nottingham Children's Hospital Completed
Nottingham, United Kingdom, NG7 2UH
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: James Weitz         
Principal Investigator: James Weitz         
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     History of Changes
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: July 11, 2019
Last Verified: July 2019

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
Signs and Symptoms
Analgesics, Opioid
Naloxegol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists