Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:36 AM
Study NCT ID:
NCT07310927
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alginate vs Sucralfate for GERD Symptomatic Relief
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000464', 'term': 'Alginates'}, {'id': 'C007829', 'term': 'alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination'}, {'id': 'D013392', 'term': 'Sucralfate'}], 'ancestors': [{'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013865', 'term': 'Thioglycosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013395', 'term': 'Sucrose'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life in Reflux and Dyspepsia', 'timeFrame': 'Before Treatment, At 4 weeks, At 6 Weeks', 'description': 'This involves questionnaire related to the symptoms and impact on quality of life.\n\nThe total score is 140, ranging from 0 to 140, the higher the score the worse will be the symptoms.'}], 'secondaryOutcomes': [{'measure': 'Adverse Effects and Tolerability', 'timeFrame': 'Before Treatment, At 2 weeks, At 4 Weeks', 'description': 'Using Structured AE Forms and A 5-Point Tolerability Scale'}, {'measure': 'Gerd Symptom Severity', 'timeFrame': 'Before Treatment, At 2 weeks, At 4 Weeks', 'description': 'Using the 0-4 GERD Symptom Severity Scale, total number of items 20. Total score is 80, ranging from 0 to 80, the higher the score the worse will be the symptoms.'}, {'measure': 'Quality of Life (QOLRAD)', 'timeFrame': 'Before Treatment, At 2 weeks, At 4 Weeks', 'description': 'Using The Validated 0-4-Point Likert QOLRAD Questionnaire, total number of items is 15.Total score is 60, ranging from 0 to 60, the higher the score the worse will be the symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GERD']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus. It is one of the most commonly diagnosed digestive disorders in the young adult population with a prevalence of 20%. Clinically GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Several causative factors have been identified and implicated in the pathogenesis of GERD, like motor abnormalities such as esophageal dysmotility clearance, decrease tone of the lower esophageal sphincter (LES), transient LES relaxation, and delayed gastric emptying, and others are anatomical defects like hiatus hernia and obesity 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+.Alginate reacts with gastric acid, forming a gel-like raft that floats on the stomach contents. The raft acts as a physical barrier, preventing acid from reaching the esophagus. Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations. This randomized clinical trial will oversee the effects of alginates versus sucralfate for GERD symptomatic relief in combination with proton pump inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients having symptoms of severe GERD for more than 3 times /week\n\nExclusion Criteria:\n\n1. Patients with preexisting cardiovascular disorders\n2. Patients with chronic kidney or liver diseases\n3. Patients with gross abnormalities on upper GI endoscopies e.g.; ulcers, tumors or those with history of upper GI surgery\n4. Pregnant and breast feeding\n5. Absence of Erosive esophagitis\n6. Patients with peptic esophageal ulcers\n7. PPI use within 4 weeks'}, 'identificationModule': {'nctId': 'NCT07310927', 'briefTitle': 'Alginate vs Sucralfate for GERD Symptomatic Relief', 'organization': {'class': 'OTHER', 'fullName': 'CMH Lahore Medical College and Institute of Dentistry'}, 'officialTitle': 'Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS', 'orgStudyIdInfo': {'id': '580/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alginate Group', 'description': 'Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.', 'interventionNames': ['Drug: Alginate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sucralfate Group', 'description': 'Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.', 'interventionNames': ['Drug: Sucralfate']}], 'interventions': [{'name': 'Alginate', 'type': 'DRUG', 'otherNames': ['Gaviscon'], 'description': '2 Table spoon spoon suspension syrup twice a day before meal.', 'armGroupLabels': ['Alginate Group']}, {'name': 'Sucralfate', 'type': 'DRUG', 'otherNames': ['Ulsanic'], 'description': '2 Table spoon spoon suspension syrup twice a day before meal.', 'armGroupLabels': ['Sucralfate Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54180', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad N Nasir, MBBS', 'role': 'CONTACT', 'email': 'nabeelnasir2004@live.com', 'phone': '00923454500293'}, {'name': 'Muhammad Hafeez, MBBS, FCPS', 'role': 'CONTACT', 'phone': '00923338555260'}], 'facility': 'Cmh Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Muhammad N Nasir, MBBS', 'role': 'CONTACT', 'email': 'nabeelnasir2004@live.com', 'phone': '00923454500293'}, {'name': 'Muhammad Hafeez', 'role': 'CONTACT', 'phone': '00923338555260'}], 'overallOfficials': [{'name': 'Muhammad Hafeez, MBBS', 'role': 'STUDY_CHAIR', 'affiliation': 'CMH Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMH Lahore Medical College and Institute of Dentistry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}