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PROCTOKINASE in acute pelvic inflammatory disease
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9 February 2023 - 4:18pm
by Gladys
13 February 2023 - 12:09pm
by lazara
Changes to
Record Verification Date
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2023/02/
09
+
2023/02/
13
Changes to
Next update date
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2024/02/
09
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2024/02/
13
Revision of 13 February 2023 - 12:09pm:
PROCTOKINASE in acute pelvic inflammatory disease
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
Primary sponsor:
Matanzas University of Medical Sciences
Secondary sponsor:
National Coordinating Center of Clinical Trials (CENCEC)
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
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
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:
2023/02/13
Next update date:
2024/02/13
Link to the spanish version:
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