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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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12 December 2020 |
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Main ID: |
NCT02405104 |
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Date of registration:
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27/03/2015 |
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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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Chlorzoxazone in Hip and Knee Arthroplasty
chlorzoxazon |
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Scientific title:
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Analgetic Effects of Chlorzoxazone in Total Hip and Knee Arthroplasty |
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Date of first enrolment:
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September 1, 2015 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02405104 |
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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. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Mogens Laursen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northern Orthopaedic Division, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Planned primary unilateral THA or TKA
- Patients (male/female) = 18 år
- Patients giving written informed consent and authority.
- Patients receiving spinal anaesthesia
Exclusion Criteria:
- Patients with intolerance to trial medications
- Rejection of or contraindicated spinal anaesthesia
- Patients with rheumatoid arthritis.
- Patients with Body Mass Index (BMI) = 35
- Patients that do not read or write Danish
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Osteoarthritis of Hip
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Intervention(s)
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Drug: Placebo
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Drug: chlorzoxazone
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Procedure: TKA
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Procedure: THA
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Primary Outcome(s)
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Pain after 5 meter walk
[Time Frame: 24 hours post OP]
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Secondary Outcome(s)
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Oxford Hip/Knee score
[Time Frame: 7 days post OP]
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Pain at rest
[Time Frame: until 12 months after surgery]
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worst pain for the last 24 hours
[Time Frame: until 12 months after surgery]
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Secondary ID(s)
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ON-151-MU-Klorz
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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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