Bangalore, karnataka annexure II proforma for registration of subjects for dissertation




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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION



1

Name of the candidate & address




Dr. PRADEEP KUMAR .B.T

“ARUNODAYA” H.NO:88/A, MIG-1, BT BED 2nd STAGE, KUVEMPU NAGAR, HASSAN, KARNATAKA-573201.




2

Name of the institution


BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE-02





3

Course of study and subject



M.D in PHARMACOLOGY




4

Date of admission to the course



20.6.2012




5

Title of topic


A COMPARATIVE PROSPECTIVE STUDY TO ASSESS THE CLINICAL EFFICACY AND SAFETY OF PANTOPRAZOLE MONOTHERAPY VERSUS PANTOPRAZOLE AND ITOPRIDE DUAL THERAPY IN PATIENTS WITH GERD IN A TERTIARY CARE HOSPITAL”





6

7

8


Brief resume of intended work:

6.1 Need for study:

Gastroesophageal reflux disease (GERD) is a condition characterized by reflux of acid gastric contents into the esophagus, with attendant inflammation, irritation and often with erosive damage to the esophageal mucosa1.

The pathophysiology of GERD is multifactorial, the commonest being the dysfunctions of the antireflux barrier. Lower esophageal sphincter dysfunction plays an important role in the pathogenesis of GERD with heartburn and regurgitation being the cardinal symptoms 2,3,4.

The prevalence of GERD is high in Western population and accounts for 18.7% in Indian population5.

Proton pump inhibitors (PPIs) have been accepted as the first line treatment of GERD because of greater efficacy and faster healing rate2. PPIs like Pantoprazole cause decrease in acid production and have high healing rates and rates of resolution of reflux symptoms at 4 weeks, but they do not help to improve underlying disturbance in gut motility or improve the tone of cardiac sphincter6.

Itopride, a novel gastro prokinetic agent stimulates gastrointestinal motor activity through dual mode of action, acting as dopamine D2 receptor antagonist and cholinesterase inhibitor. It has an antiemetic action, accelerates gastric emptying and modulates gastric sensorimotor function4.

The combination is synergistic by decreasing acid production as well as increasing lower esophageal tone and esophageal clearance, thus providing a better therapeutic response.

In view of problems with tolerability with other prokinetic drugs, also there is paucity of literature with combination of pantoprazole and itopride in GERD, the present study has been taken up.



6.2 Review of Literature:

Gastro-oesophageal reflux disease (GERD) is characterized by the reflux of gastric content into oesophagus with or without histological changes4. Although most cases follow a relatively benign course, GERD in some individuals can cause severe erosive esophagitis, serious sequelae include stricture formation and Barrett's metaplasia which, in turn is associated with a small, but significant risk of adenocarcinoma4,7.


The goals of GERD therapy are complete resolution of symptoms and healing of esophagitis7. Proton pump inhibitors clearly are more effective than H2-receptor antagonists in achieving these goals7. Healing rates after 4 weeks and 8 weeks of therapy with proton pump inhibitors are approximately 80% and 90% respectively, while the corresponding healing rates with H2-receptor antagonists are 50% and 75% respectively7.

A study by A.Dettmer et al has shown that low dose pantoprazole is clinically superior to ranitidine in providing fast relief from symptoms and healing of lesions in patients with mild GERD8.

A study by Scholten T et al has shown that treatment with pantoprazole resulted in significantly faster first time relief from daytime and night time GERD related symptoms than esomeprazole9.

A study by Krishnakanth K et al to check the efficacy of pantoprazole alone versus pantoprazole and itopride have showed that the combination therapy to have a greater efficacy than pantoprazole alone10.

A study by Yong Sung Kim has showed that itopride is found to be effective in decreasing the pathologic reflux in patients of mild GERD4.

A study by E.Scarpellini has proved that itopride inhibits Transient lower esophageal relaxations without affecting esophageal peristaltic function or LES pressure and has been found to be effective in the treatment of GERD11.



6.3 Aims and Objectives:

  1. To assess the efficacy of pantoprazole monotherapy versus pantoprazole and itopride dual therapy in patients with GERD.

  2. To assess the safety and tolerability of pantoprazole monotherapy versus pantoprazole and itopride dual therapy in patients with GERD.

MATERIALS AND METHODS:

7.1 Source of data:

Outpatients attending the department of surgical gastroenterology, Victoria hospital, Bangalore.



    1. Methods of collection of data:

  1. Study design: Open label comparative, prospective study.

  2. Study period: Nov 2012- Oct 2014.

  3. Sample design: Random sampling.

  4. Sample size: 100 patients.

  • After obtaining approval and clearance from the institutional ethics committee, patients will be included for the study.

  • The study subjects fulfilling the inclusion criteria will be randomly assigned into 2 groups of 50 patients in each.

Group A: Patients treated with Pantoprazole alone.

Group B: Patients treated with pantoprazole and itopride.



  1. Inclusion Criteria :

  1. Patients of either sex aged between 18-60 years.

  2. More than one upper dyspeptic symptoms such as regurgitation, epigastric pain, nausea, vomiting, dysphagia, chest pain lasting for more than 4 weeks, Frequency Scale for the Symptoms of GERD score >8.

  3. Grade I-III esophagitis by Savary-Miller classification by endoscopic examination.

  4. Patient willing to give written informed consent.

F. Exclusion Criteria:

  1. Corrosive esophagitis by a toxicant.

  2. Esophagitis due to inflammatory infection or radiotherapy.

  3. Regular use of H2 blockers, prokinetic or anticholinergic agents for previous 4 weeks.

  4. Previous gastrointestinal surgery.

  5. Inflammatory bowel disease.

  6. Cardiological, respiratory, gastrointestinal disease, endocrine metabolic disease and neuro-psychological disease.

  7. Clinically significant hepatic or renal dysfunction.

  8. Pregnant and lactating women.

G.Methodology:

100 patients diagnosed with GERD by FSSG scores and endoscopy and also patients who fulfilled the inclusion criteria will be enrolled in the study after obtaining informed consent and they will be randomly assigned into two different treatment groups. Demographic data, history, clinical examination and details of drug prescription by the treating gastroenterologist will be recorded in the study proforma.

Group A will receive tablet pantoprazole 40 mg twice daily alone 30 minutes before food for 4 weeks.

Group B will receive tablet pantoprazole 40 mg twice daily and tablet itopride 50 mg thrice daily 30 minutes before food for 4 weeks.

Both the groups are advised to avoid alcohol and smoking during the study period.

The patients will be followed up at the end of 4th week and are given the questionnaire to assess the FSSG scores. Endoscopy and FSSG scores are recorded and then the percentage of responders in both groups will be compared.



H. Assessment tools:

  • FSSG score and endoscopy to diagnose GERD.

  • A thorough physical/ gastro enterological evaluation will be carried out and recorded in the protocol.(Annexure-3)

  • Efficacy will be assessed by:

- Improvement in FSSG scores (Annexure-4).

- Endoscopic healing of esophagitis (Annexure-4).



  • Safety will be evaluated by:

- Recording clinical adverse drugs reactions.

- Further, the adverse drug reactions will be classified according to their type, severity, and causality.

- Incidence of side effects will be assessed using a standardized questionnaire given to the patient at the time of enrollment and to be filled in during treatment period, indicating the type and degree of interference with daily activity of the patient (Annexure-5) and also by clinically significant abnormal laboratory investigations.

- Tolerability will be analyzed in all compliant patients based on the side effects grading (annexure-7).


  • Relevant laboratory investigations :

-Complete blood count, ECG, Random blood sugar, blood urea, serum creatinine, SGOT, SGPT.(Annexure-6)

  1. The detailed schedule of patient visit is as follows :

Baseline assessment-

  • After initial screening patients will be informed fully about the purpose and requirements of the study and written informed consent will be obtained (Annexure-1).

  • Each patient, who satisfies all the inclusion criteria including routine laboratory investigations, will qualify for the study.

  • Details of patient’s demographic characteristics, medical history, and concomitant medication, history of habits, detailed physical examination and clinical findings will be recorded (Annexure-3).

  • Patients will be issued four week medication and advised to take medication as prescribed.

  • The patient will be instructed to return for clinical assessment after four week and to bring the medication kit with any tablets remaining unutilized.

  • All observed or spontaneously volunteered adverse events will be recorded.

  • Clinical examination will be repeated.

  • FSSG scores will be recorded.

  • Endoscopy will be done.

  1. Statistical analysis:

Parametric variables will be analyzed using student t test and z test.

Non parametric variables will be analyzed using Fischer exact test and Chi- square test.

Any other suitable statistical method will be used at the time of data analysis after consulting bio-statistician.

7.3 Does the study require any investigation to be conducted on patients or animals specify?

It does not require any animal studies.



These are the following investigations done for patients-

  • Complete blood count

  • Random blood glucose

  • Serum creatinine

  • Blood urea

  • SGOT, SGPT

  • ECG



    1. Has the ethical clearance been obtained from ethics committee of your Institution in case of 7.3

Yes, ethical clearance has been obtained from the ethics committee of Bangalore medical college and research institute.

LIST OF REFERENCES :

  1. Robinson M, Fitzgerald S, Hegedus R et al. Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis. Aliment Pharmacol Ther. 2002 Mar; 16(3):445-54

  2. Chandrasoma P.The Pathology of Gastroesophageal Reflux Disease.In: Charles J Yeo, Daniel T Dempesy, Andrew S Klein, John H Pemberton, Jeffery H Peters. Editors. Shackelford’s Surgery of the Alimentary Tract.6th ed., Elsevier.560-580

  3. Kahrilas PJ, Hirano I. Disease of the esophagus. In: Fauci AS, Braunwald E, Kasper DL, Hauser SL, Longo DL, Jameson JL et al.Editors. Harrison’s Principles of Internal Medicine. Vol. 2,18th ed., McGraw hill, New York: 2012: 2427-2437

  4. Kim Y S, Kim T H, Choi C S et al.Effect of itopride new prokinetic in patients with mild GERD: A pilot study. World J Gastroenterology 2005; 11(27):4210-4214

  5. Kumar S , Sharma S & Norboo T et al. Population based study to assess prevalence and risk factors of gastroesophageal reflux disease in high altitude area. Indian society of Gastroenterology.23rd December 2010.135-149.

  6. Singhal S, Dhawan P, Bhatt A, Pokharna R et al. Evaluation of Safety and Efficacy of Pantoprazole and Domperidone Combination in Patients with Gastroesophageal Reflux Disease. The Internet Journal of Gastroenterology. 2006 Volume 4 Number 2. DOI: 10.5580/18dd.

  7. Willemijntje A. Hoogerwerf and Pasricha PJ. Pharmacotherapy of gastric acidity, peptic ulcers and gastroesophageal reflux disease.In: Laurence L. Brunton, John S Lazo, Keith L. Parker. Editors. Goodman and Gillman’s The Pharmacological Basis of Therapeutics.11th ed., McGraw hill, New York: 2006:1309-1322

  8. Dettmer A, Vogt R, Sielaff F et al: Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. Aliment Pharmacol Ther 1998; 12:865-872

  9. Scholten T, Gatz G, Hole U: Once daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD related symptoms. Aliment Pharmacology Ther 2003; 18:587-594

  10. Krishnakanth K, Siddalingappa CM, Kudagi BL et al. Efficacy of pantaprozole versus pantaprozole plus itopride in gastroesophageal reflux disease patients - A pilot study. Indian journal of Pharmacology. 2011; 43:205-8

  11. Scarpellini E, Vos R, Blondeau K, Boecxstaens V et al. The effect of itopride on oesophageal motility and lower oesophageal sphincter function in man. Aliment Pharmacol and Ther 2011; 33: 99–105




9
SIGNATURE OF CANDIDATE




10

REMARKS OF THE GUIDE


GERD is one of the commonest esophageal disorder, the combination of pantoprazole and itopride is synergistic by decreasing acid production as well as increasing LES tone with better therapeutic response. Hence the present study is taken up.

11
NAME AND DESIGNATION OF

11.1 GUIDE

Dr. K.R.MAMATHA MD.

Professor, Department of Pharmacology, Bangalore Medical College & Research Institute, Bangalore.





    1. SIGNATURE





    1. CO-GUIDE





Dr. N.S.NAGESH MS , FSGE , DNB.

Associate Professor, Department of Surgical Gastroenterology, Bangalore Medical College & Research Institute, Bangalore.





    1. SIGNATURE







11.5 HEAD OF THE DEPARTMENT

Dr. C.R.JAYANTHI MD.

Professor and Head, Department of Pharmacology, Bangalore Medical College & Research Institute, Bangalore.





    1. SIGNATURE




12
12.1 REMARKS OF CHARIMAN AND PRINCIPAL






12.2 SIGNATURE









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