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Main
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Note: This record shows only 22 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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20 April 2015 |
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Main ID: |
NCT02416141 |
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Date of registration:
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31/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.
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Scientific title:
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Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration. |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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128 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02416141 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Michael De Brucker, MD |
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Address:
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Telephone:
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003224776699 |
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Email:
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Affiliation:
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Name:
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Michael De Brucker |
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Address:
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Telephone:
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Email:
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Affiliation:
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UZ Brussel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- - Patients above 18 ans.
- Non desired pregnancy.
- Non evolutive pregnancy.
- Pregnancy < or = 14 weeks of amenorrhea.
Exclusion Criteria:
- - Interruption of pregnancy due to medical reasons
- Patient already included in this study
- Intolerance for Tradonal Odis 50mg
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fertility
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Intervention(s)
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Drug: fast release oro dispersible tramadol 50 mg
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Primary Outcome(s)
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Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial.
[Time Frame: 6 to 8 month to include all patients]
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Secondary ID(s)
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CHUTIV2015MDB001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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