Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/02/2011
Date assigned
07/04/2011
Last edited
01/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stanislaw Pomianowskip

ORCID ID

Contact details

Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny
im. Prof. Adama Grucy
ul. Konarskiego 13
Otwock
05-400
Poland

Additional identifiers

EudraCT number

2010-020973-18

ClinicalTrials.gov number

Protocol/serial number

2010-020973-18

Study information

Scientific title

Effect of treatment with L0006CP on the time of fracture-healing: a prospective, multi-centre, double-blind, randomised, placebo controlled clinical trial

Acronym

L0006CP

Study hypothesis

To compare the effect of a treatment with ossein L0006CP compound versus a placebo on the time of fracture-healing in patients with a wrist fracture

Ethics approval

Not provided at time of registration.
Bioethical committee of Centre for Medical Education, Warsaw (Centrum Medyczne Kształcenia) - approval pending

Study design

Prospective multicentre double-blind randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Wrist fracture

Intervention

L0006CP film-coated tablets OR placebo tablets for 12 weeks (1 tablet twice a day)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Comparison between the two treatments, of the time to radiological healing in the two groups

Secondary outcome measures

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

Overall trial start date

15/03/2011

Overall trial end date

15/10/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant 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

Recruitment start date

15/03/2011

Recruitment end date

15/10/2011

Locations

Countries of recruitment

Poland

Trial participating centre

Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny
Otwock
05-400
Poland

Sponsor information

Organisation

Pierre Fabre (France)

Sponsor details

Canceropole
3 Avenue Hubert Curien
BP13562
Toulouse Cedex
31035
France

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Pierre Fabre (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes