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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00474799 |
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Date of registration:
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15/05/2007 |
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Primary sponsor: |
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Public title:
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Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)
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Scientific title:
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An Open Label, Randomized, Single Center, Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine) in Opioid naïve, Healthy Adult Volunteers |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00474799 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Javelin Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Javelin Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy adult volunteers 18 years of age or older
Exclusion Criteria:
- History of alcohol, drug addiction, or substance abuse.
- Known to or suspected to be currently abusing alcohol or drugs.
- Allergy or hypersensitivity to shellfish or opioids.
- History of seizures.
- Clinically significant structural or functional abnormalities of the nose and upper
airway, obstruction of the nasal passages, or mucosal lesions of the nostrils.
- Smoked or used tobacco or nicotine products in the past six months or expects to
during the study.
- Positive for hepatitis B or hepatitis C or HIV antibodies.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: MNS075
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Primary Outcome(s)
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To characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075.
[Time Frame: Multiple]
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Secondary ID(s)
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MOR-PK-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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