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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05174845
Other study ID # PLEN-01/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date March 1, 2022

Study information

Verified date May 2022
Source Norgine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.


Description:

Observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data). The design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. The design, therefore, avoids the possible risk of the dissemination of the personal data of patients.


Recruitment information / eligibility

Status Completed
Enrollment 13393
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male and female outpatients aged: =18 years undergoing a screening, surveillance, or diagnostic colonoscopy between June 1, 2019, to September 1, 2021 - Who have used NER1006 in the preparation of the colonoscopy either in split doses or same day. Exclusion Criteria: - History of colorectal cancer o colectomy before the first colonoscopy - Impossibility to obtain the required mandatory data

Study Design


Intervention

Drug:
1L PEG + ASCORBIC ACID
2-Day Split-Dosing: The patient has taken the product in the evening before the scheduled colonoscopy and mandatory additional clear fluid. The patient has taken the second dose with mandatory additional clear fluids on the morning of the colonoscopy. Same Day: The patient has taken the first dose of the product on the day of the colonoscopy and take mandatory additional clear fluid. After a 1-2 hour break, the patient has taken a second dose plus additional clear mandatory fluid.

Locations

Country Name City State
Portugal Hospital da Senhora da Oliveira Guimarães
Portugal Hospital CUF Descobertas Lisboa
Spain Hospital San Rafael A Coruña
Spain HM Sant Jordi Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Doctor López Cano Cadiz
Spain Complejo hospitalario Ruber Juan Bravo Madrid
Spain Hospital Clinico San Carlos Madrid
Spain Hospital La Zarzuela Madrid
Spain Consorci Corporació Sanitària Parc Taulí Sabadell Barcelona
Spain Hospital Quirón salud Sagrado Corazón Sevilla
Spain Consorcio Hospitalario Provincial de Castelló Valencia

Sponsors (2)

Lead Sponsor Collaborator
Norgine Xolomon Tree S.L.

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients With Successful Bowel Cleansing (Overall Colon) The proportion of patients with adequate total colon cleansing is defined as a Boston Bowel preparation scale (BBPS) score = 2 in all segments (BBPS> 6). Up to 2 days (from day of first dosing to day of colonoscopy)
Primary Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens) Proportion of patients with a high-quality cleaning in the right colon defined as a BBPS score = 3. Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Polyps Detection Rate in the total colon and in the right colon Proportion of colonoscopies where at least one polyp was found and removed in total and right colon Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Adenoma Detection Rate in the total colon and in the right colon Proportion of colonoscopies where at least one adenoma is found based on histological analysis in total and right colon Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Cecal intubation rate Defined as the visualization of the ileocecal valve and / or appendicular orifice Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Cecal intubation time Defined as the time required for the introduction of the colonoscope to reach the base of the cecum. Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Withdrawal time Defined as the minutes spent inspecting the colon wall. Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Tolerability of the preparation, if available Defined as good, fair or poor. Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Tolerability of the preparation, if available Defined with a semi-quantitative scale of 1-5 (1 = totally agree, 2 = agree, 3 = Neutral, 4 = disagree, 5 = totally disagree) Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Adherence to the preparation, if available. Percentage of patients with adherence to the preparation, defined as ingestion of at least 75% of each of the two doses Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Treatment satisfaction, if available Percentage of patients satisfied with the preparation Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Safety of the preparation Safety from registered adverse effects. Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Sub-analyzes will be conducted in different patient populations Patients = 65 years, patients with chronic constipation, with diabetes mellitus, with hypertension, with mild to moderate renal failure and with inflammatory bowel disease. Up to 2 days (from day of first dosing to day of colonoscopy)
Secondary Sub-analyzes of the primary and secondary outcomes Sub-analyzes will be carried out by country, by the reason for the colonoscopy and by the recommended dietary regimen Up to 2 days (from day of first dosing to day of colonoscopy)
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