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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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4 May 2013 |
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Main ID: |
CTRI/2009/091/000913 |
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Date of registration:
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19-11-2009 |
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Primary sponsor: |
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Public title:
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A clinical trial to study the effects of two drugs, Lafutidine and Rabeprazole in the Treatment of heartburn-dominant uninvestigated dyspepsia.
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Scientific title:
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A Multi-centric, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Lafutidine versus Rabeprazole in the Treatment of heartburn-dominant uninvestigated dyspepsia. |
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Date of first enrolment:
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20-08-2009 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1068 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label
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Countries of recruitment
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India
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Contacts
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Name:
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Dr. Bhupesh Dewan
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Address:
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5119-'D' Wing, Oberoi Garden Estate Chandivilli,
400 072
Mumbai, MAHARASHTRA
India |
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Telephone:
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30610000 |
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Email:
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Bhupesh.Dewan@zuventus.com |
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Affiliation:
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Name:
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Dr Bhupesh Dewan
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Address:
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5119-D Wing, Oberoi Garden Estate Chandivilli,
400 072
Mumbai, MAHARASHTRA
India |
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Telephone:
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30610000 |
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Email:
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Bhupesh.Dewan@zuventus.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients aged 18 years or older.
2. Patients having a minimum of 1--month history of dyspepsia (including symptoms of heartburn and/or epigastric pain and/or bloating) with at least one moderate to severe symptom [score>/= 4 on a 7-point Global Overall Symptom (GOS) scale] on at least three of the 7 days before randomization.
a. Heartburn is defined as "a burning feeling rising from the stomach or lower part of the chest up towards the neck".
b. Epigastric pain is defined as "pain in the middle of the upper abdomen just below the breastbone".
c. Abdominal Bloating defined as "Excess gas in the intestines leading to discomfort associated with fullness of the abdomen".
3. Patients willing to give written informed consent and willing to comply with trial protocol
Exclusion criteria: 1. Patients showing alarm features (unintentional weight loss, persistent vomiting, dysphagia, haematemesis, melaena, fever, jaundice, or anaemia), irritable bowel syndrome or serious concomitant disease.
2. Patients with a history of gastrointestinal disease (including peptic ulcers, malignancy, oesophageal dysmotility and a previous endoscopic or radiological diagnosis of GERD and Barrett's oesophagus), recent gastrointestinal surgery i.e. within 30 days (except appendectomy, colonic resection and cholecystectomy).
3. Patients who had been treated with NSAIDs, ASA (>325 mg/day), H2-RAs, PPIs, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment.
4. Patients who had previously been included or who had participated in any other clinical trial within the last month.
5. Patients with a known history of hypersensitivity to study medications.
6. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study.
7. Patients who are drug or alcohol abusers or suffering from any other condition associated with poor compliance.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Uninvestigated Dyspepsia
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Intervention(s)
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Intervention1: Lafutidine: One Lafutidine (10 mg) tablet to be taken once daily for 28 days.
Control Intervention1: Rabeprazole.: One Rabeprazole (20 mg) tablet to be taken once daily for 28 days.
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Primary Outcome(s)
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proportion of patients with symptom relief defined as a score of 2 or less on GOS scaleTimepoint: after 2 & 4 weeks of treatment.
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Secondary Outcome(s)
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Overall Patient Satisfaction: Defined As A Score Of 3 Or Less.Timepoint: after 2 & 4 weeks of treatment.
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Patient Perspective On Symptom Relief: Defined As A Score Of 4 or moreTimepoint: after 2 & 4 weeks of treatment.
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Symptom Improvement [difference of GOS Score: 2 or more]Timepoint: after 2 & 4 weeks of treatment.
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Symptom resolution [GOS score=1]Timepoint: after 2 & 4 weeks of treatment.
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Secondary ID(s)
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Emc/GASTR/LAFUT/12/2008
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Source(s) of Monetary Support
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Zuventus Healthcare Ltd.
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