NCT07310927

Brief Summary

Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus.It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Sucralfate is a unique anti-ulcer drug and is a basic aluminum salt of sucrose octa-sulfate. It forms a protective layer, enhancing bicarbonate production, demonstrating anti-peptic properties, and fostering tissue growth, regeneration, and repair and it undergoes minimal enteral reabsorption. Alginate is a naturally occurring anionic polymer typically obtained from brown seaweed and has been extensively investigated and used for many biomedical applications, due to its biocompatibility, low toxicity, relatively low cost, and mild gelation by addition of divalent cations such as Ca2+.Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2025

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

April 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

December 16, 2025

Last Update Submit

April 19, 2026

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

  • Quality of Life in Reflux and Dyspepsia

    This involves questionnaire related to the symptoms and impact on quality of life. The total score is 140, ranging from 0 to 140, the higher the score the worse will be the symptoms.

    Before Treatment, At 4 weeks, At 6 Weeks

Secondary Outcomes (3)

  • Adverse Effects and Tolerability

    Before Treatment, At 2 weeks, At 4 Weeks

  • Gerd Symptom Severity

    Before Treatment, At 2 weeks, At 4 Weeks

  • Quality of Life (QOLRAD)

    Before Treatment, At 2 weeks, At 4 Weeks

Study Arms (2)

Alginate Group

EXPERIMENTAL

Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.

Drug: Alginate

Sucralfate Group

ACTIVE COMPARATOR

Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.

Drug: Sucralfate

Interventions

AlginateDRUG

2 Table spoon spoon suspension syrup twice a day before meal.

Also known as: Gaviscon
Alginate Group
SucralfateDRUG

2 Table spoon spoon suspension syrup twice a day before meal.

Also known as: Ulsanic
Sucralfate Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients having symptoms of severe GERD for more than 3 times /week

You may not qualify if:

  • Patients with preexisting cardiovascular disorders
  • Patients with chronic kidney or liver diseases
  • Patients with gross abnormalities on upper GI endoscopies e.g.; ulcers, tumors or those with history of upper GI surgery
  • Pregnant and breast feeding
  • Absence of Erosive esophagitis
  • Patients with peptic esophageal ulcers
  • PPI use within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cmh Lahore

Lahore, Punjab Province, 54180, Pakistan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Alginatesalginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combinationSucralfate

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydratesThioglycosidesSulfur CompoundsOrganic ChemicalsSucroseDisaccharidesOligosaccharidesSugars

Study Officials

  • Muhammad Hafeez, MBBS

    CMH Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

April 1, 2025

Primary Completion

March 30, 2026

Study Completion

April 15, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)