NCT05828836

Brief Summary

The study aims to evaluate the impact of allopurinol on patients' related quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

April 12, 2023

Last Update Submit

October 29, 2023

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Chronic liver disease questionnaire

    effect on Chronic liver disease questionnaire score

    6 months

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: Placebo

allopurinol

ACTIVE COMPARATOR
Drug: Allopurinol Tablet

Interventions

Allopurinol TabletDRUG

allopurinol300mg once daily

allopurinol
PlaceboDRUG

placebo once daily

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhosis adult both sex

You may not qualify if:

  • renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy

Tanta, 31679, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

June 15, 2022

Primary Completion

January 15, 2023

Study Completion

March 1, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

EG(1)