PROCTOKINASE in acute pelvic inflammatory disease

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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:

Efficacy and safety of the PROCTOKINASA® suppository in the treatment of acute pelvic inflammatory disease in Primary Care

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Matanzas University of Medical Sciences

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:

Diriana

Midle name:

Barbara

Last name:

Sanchez Perez

Medical Specialty :

First Degree Specialist in Integral General Medicine and Pharmacology

Affiliation:

University of Medical Sciences “Dr. Juan Guiteras Gener "

Postal address:

Carretera Central Km 102

City:

Matanzas

Country:

Cuba

Zip Code:

40100

Telephone:

+53-45295266

Email address:

diriana@ucm.mtz.sld.cu

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:

Matanzas, Samuel Fernandez Teaching Polyclinic, Arialys Guerra Balceiro PhD, Second Degree Specialist in Pharmacology

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

01/06/2016

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:

pelvic inflammatory disease

Health condition(s) code:

Pelvic Inflammatory Disease

Pelvic Infection

Adnexal Diseases

Genital Deseases, Female

Genital Deseases

Female Urogenital Desease

Female Urogenital Desease and Pregnancy Complications

Urogenital Desease

Intervention(s):

Group 1: 200 mg PROCTOKINASE suppository rectally every 8 hours for 48 hours + schedule A or B. Group 2: 20 mg Piroxican suppository rectally every 8 hours for 48 hours + schedule A or B. Schedule A: Tetracycline (250mg) 2tbs every 8hrs + Metronidazole (250mg) 2tbs every 12hrs for 7 days Scheme B: Ciprofloxacin (250mg) 2tbs every 12hrs + Metronidazole (250mgs) 2tbs every 12hrs for 7 days

Intervention code:

Suppositories

Piroxicam

Administration, Rectal

Tetracycline

Metronidazole

Ciprofloxacin

Tablets

Administration, Oral

Intervention keyword:

proctokinase

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 severity. Pain resolution time (pain analogue scale: Much better, Better, No change, Worse, Much worse). Measurement time: on the 3rd, 5th, 10th day and on the 15th day. Measurement time: on the 3rd, 5th, 10th day and on the 15th day.

Key secondary outcomes:

Evolution of ultrasound findings (transvaginal ultrasound). Measurement time: baseline and after 5 days of treatment. Adverse Events-AE (Occurrence of any AE in the subject (yes/no); Description of the AE (Name of the adverse event); Duration of the AE (Difference in dates between the start and end of the event); Intensity of the AE (Mild , Moderate, Severe); AE severity (Serious/serious, Not serious/not serious); Attitude towards study treatment (no change, dose modification, temporary or permanent discontinuation of study treatment); AE outcome (recovered , improved, persists or sequelae); Causal relationship (1.Very Probable, 2.Probable, 3.Possible, 4.Improbable, 5.Not related, 6.Not evaluable)). Measurement time: up to 15 days of patient follow-up.

Selection criterias

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

Gender:

Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1. Female patients with a clinical and ultrasound diagnosis of mild and moderate acute pelvic inflammatory disease who have signed the informed consent. 2. Patients over 18 years of age. 3. Patients who do not require hospitalization.

Exclusion criteria:

1. Patients who are participating in another clinical trial. 2. Breastfeeding patients. 3. Patients with a history of hypersensitivity to the product or to any of the components of the formulation. 4. Female patients with a clinical and ultrasound diagnosis of severe PID or with criteria for hospitalization. 5. Patients with surgery for less than 7 days, active bleeding or previously diagnosed bleeding disorder. 6. Patients with a diagnosis of arterial hypertension.

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:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

76

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:

Maria

Middle Name:

Acelia

Last Name:

Marrero Miragaya

Specialty:

First Degree Specialist in Surgery

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC)

Postal Address:

5ta. A entre 60 y 62, Miramar

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164222

Email :

acelia@cencec.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:

Maria

Middle Name:

Acelia

Last Name:

Marrero Miragaya

Specialty:

First Degree Specialist in Surgery

Affiliation:

National Coordinating Center for Clinical Trials

Postal Address:

5ta. A entre 60 y 62, Playa

City:

La Habana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164222

Email :

acelia@cencec.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

University of Medical Sciences “Dr. Juan Guiteras Gener "

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

20/01/2017

Postal address of Ethic Committee :

Carretera Central Km 102 CP. 40100, Matanzas, Cuba

Telephone:

+53-45266414

Email:

biblioucm.mtz@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

76

Study completion date:

01/12/2021

Date of available results:

01/12/2021

Date of first publication:

01/12/2021

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:

RPCEC00000416

Date of Registration in Primary Registry:

09/02/2023

Record Verification Date:

2023/02/09

Next update date:

2024/02/09

Link to the spanish version:

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Registered Trials

Registration process

PROCTOKINASE in acute pelvic inflammatory disease

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