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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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ISRCTN |
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Last refreshed on:
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17 June 2019 |
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Main ID: |
ISRCTN71678602 |
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Date of registration:
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07/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of treatment with L0006CP on the time of fracture-healing
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Scientific title:
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Effect of treatment with L0006CP on the time of fracture-healing: a prospective, multi-centre, double-blind, randomised, placebo controlled clinical trial |
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Date of first enrolment:
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15/03/2011 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN71678602 |
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Study type:
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Interventional |
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Study design:
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Prospective multicentre double-blind randomised placebo controlled trial
(Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Poland
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Contacts
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Name:
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Stanislaw
Pomianowskip |
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Address:
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Klinika Chirurgii Urazowej Narzadu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny
im. Prof. Adama Grucy
ul. Konarskiego 13
05-400
Otwock
Poland |
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Email:
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Affiliation:
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Name:
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Address:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Male or menopausal female between 50 and 80 years of age
2. A recent closed Colles fracture, correctly reduced and stabilised
3. Willing, able to understand and sign an approved informed consent form
4. Able to understand the protocol and to come to the control visits
Exclusion criteria:
1. Fractures not meeting inclusion criteria (including pathological fractures)
2. Previous or concomitant treatment that may influence recovery
3. Concomittant treatments interfering with bone metabolism
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wrist fracture
Injury, Occupational Diseases, Poisoning
Wrist fracture
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Intervention(s)
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L0006CP film-coated tablets OR placebo tablets for 12 weeks (1 tablet twice a day)
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Primary Outcome(s)
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Comparison between the two treatments, of the time to radiological healing in the two groups
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Secondary Outcome(s)
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Comparison between the two groups of:
1. Time to disappearance of fracture line
2. Time to full normal activity of daily living involving the target upper limb
3. Percentage of patients with at least one adverse event occurring under treatment
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Secondary ID(s)
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2010-020973-18
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Source(s) of Monetary Support
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Pierre Fabre (France)
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration.
Bioethical committee of Centre for Medical Education, Warsaw (Centrum Medyczne Ksztalcenia) - approval pending
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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15/10/2011 |
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URL:
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