Lidoment - pain osteomioarticular - phase IV | Registro Público Cubano de Ensayos Clínicos

Lidoment - pain osteomioarticular - phase IV

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Lidoment, analgesic medicamental formulation for relief of the pain in the system osteomioarticular.

Source(s) of monetary or material support:

Ministry of Public Health, Cuba.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Malena de los Milagros Zelada Pérez

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

No

Research ethics committees:

Policlinical Vedado, June 15th, 2007

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

30/06/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Pain

Intervention(s):

Daily topical application of the analgesic gel, during 7 days. The formulation contains the mixture of Lidocaine 5% - 30 ml and Menthol 1%.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Pain (analogue pain scale,0-10, 0 is no pain and 10 is the worst imaginable pain). Measurement time: Daily by the patient, 7 days after begining the treatment by the doctor.

Key secondary outcomes:

Osteomioarticular system lesions (description of lesions). Measurement time: 7 days after begining the treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

80 years

Inclusion criteria:

1.Patient of any age, sex and ethnic group that are remitted by the specialist in Anesthesiology, of the service of integral Rehabilitation of the Vedado Policlinical, payees of pains osteomioarticulars, which were remitted to their consultation to be valued and treaties. 2.The patients' consent to participate in the trial, included in the pattern of clinical history of the pain made for the same ones.

Exclusion criteria:

a.Patients that presented some pathology like: sepsis in the affected area, oncological processes, bigger psychiatric dysfunctions and/or cerebral damage. b.The negative of the patients of participating in the investigation.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2

Target sample size:

200

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Malena

Middle Name:

de los Milagros

Last Name:

Zelada Pérez

Affiliation:

Vedado Policlinical

Postal Address:

15th. street,corner at 18, Vedado.

City:

Havana City

País:

Cuba

Zip Code:

10400

Telephone:

5378356773

Email :

mzelada@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Malena

Middle Name:

de los Milagros

Last Name:

Zelada Pérez

Affiliation:

Vedado Policlinical

Postal Address:

15th. street,corner at 18, Vedado.

City:

Havana City

País:

Cuba

Zip Code:

10400

Telephone:

5378356773

Email :

mzelada@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000094

Date of Registration in Primary Registry:

2010-03-01

Record Verification Date:

2010-01-22 19:00

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