- Guideline for the conduct of Clinical Trials in Sri Lanka Version and Revision Number/Code: V 5.0 / Rev No: 0
- Supplementary information for license to import Medicine/Medical device/Borderline products as samples for Clinical Trial purpose
- Guideline on Non routine processing of clinical trial applications & conduct of clinical trial during Emergency situation
- Guideline on safety reporting requirements for clinical trials
- Guideline for the Management of Investigational Medicinal Products
- Guideline on Good Clinical Practice inspection
- Application for amendments to a clinical trials
- Guideline for amendments (changes) to clinical trials
- Guidelines for the recognition of Ethics Review Committee
| Reference No. | Study title | Principal Investigator | Sponsor | Investigational Product | Status/Outcome |
| CTM/027/2022 | A phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Sibeprenlimab administered subcutaneously in subjects with Immunoglobulin A nephropathy | Dr.Chula A. Herath | Otsuka Pharmaceutical Development & Commercialization, Inc, USA | Sibeprenlimab | Approved on 20.09.2022 |
| CTM/028/2022 | A phase 2a, multicenter, open-label study to evaluate the safety and efficacy of AT-1501 in patients with IgA nephropathy | Dr.Chula A. Herath | Eledon Pharmaceuticals, Inc, USA | Humanized IgG1 Kappa monoclonal anti-CD40LG antibody | Approved on 21.04.2022 |
| CTM/029/2022 | A Phase 2/3, Multicenter, Open-label, Trial to Evaluate the Long-term Safety Tolerability and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy | Dr.Chula A. Herath | Otsuka Pharmaceutical Development & Commercialization, Inc, USA | Sibeprenlimab | Approved on 19.10.2022 |
| CTM/030/2022 | Double-blind randomized controlled trial to investigate the effectiveness and safety of Retinyl Palmitate in Patients with chronic Achilles tendinopathy | Dr.Lal Ekanayake | Regenall Limited, UK | Retinyl Palmitate (Vitamin A) | Not approved as the NMRA criterias for the conduct of phase II trial has not been met |
| Reference No. | Study title | Principal Investigator | Sponsor | Investigational Product | Status/Outcome |
| CLITRI/2021/000045 | Randomized double blind controlled trial on the safety and efficiacy of investigational herbal preparation for the treatment of patients with COVID-19 | Dr. Thilanka Senavirathne | Investigator driven | Herbal prepration | Not coming under NMRA purview |
| CLITRI/2021/00049 | A parallel group, phase III, multi stage, modified double blind , multi armed study to assess the efficacy, safety and immunogenicity of two SARS- Cov 2 adjuvanted Recombinanat Protein Vaccine (monovalent & bivalanet) for prevention against COVID-19 in adults 18 years of age and older | Dr. Ananda Wijewickrama | Sanofi Pasteur Inc, Discovery Drive Swiftwater PA, USA | COVID 19 vaccine recombinant adjuvanted or CoV2 preS dTMAS03 D614B1351 Stage 2 bivalent vaccine CoV2 preS dTM AS03 D614 recombinant adjuvanted Stage 1 monovalent vaccine | Aprroved to proceeed only the stage 1 involving monovalent vaccine on 30.08.2021 |
| CLITRI/2021/00050 | Efficcacy and safety of oral ivemectin in the treatment of COVID-19 patients: a randomized double blind controlled clinical trial | Dr. Ananda Wijewickrama | Investigator driven | Ivermectin | Approved on 12.07.2021 |
| CLITRI/2021/00051 | Efficacy of nebulised Homoharringtonine on the clearance of the viral load in patients with SARS Co V2 who are under care of intermediate care center at Walahanduwa and Arachchikanda Galle A randomised placebo controlled double blind clinical trial | Prof.Sujeewa Amarasena | Hangzhou Minsheng Pharmaceutical Co Ltd, China | Omacetaxine mepesuccinate | Not approved as the saftey profile of the investigated route has not been established. |
| CLITRI/2021/00052 | Inhaled beclomethasone in the treatment of early COVID-19: a placebo controlled randomized trial | Prof.Chamila Meththananda | Investigator driven | Dry powder beclomethasone capsule | Approved on 13.07.2021 |
| CLITRI/2021/00053 | A prospective double blind parallel assignment randomised controlled study to evaluate the effectiveness and safety of high dose vitamin D supplementation and effects and associations of low vitamin D levels in patients with symptomatic SARS CoV2 infection | Dr.Manilka Sumanathilake | Investigator driven | Vitamin D-2 hydroxy cholecalceferol | Approved on 14.07.2021 |
| CTM/022/2021 | Preventing Adverse Cardiac Events (PACE) in chronic obstructive pulmonary disease (COPD) | Prof.Channa Ranasinghe | The George Institute for Global Health, Australia | Bisoprolol Fumarate | Approved on 15.11.2021 |
| CTM/023/2021 | Multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individual at risk of exposure to COVID-19 infection | Dr. Ananda Wijewickrama | SaNotize Research and Development Corp,Canada | Nitric Oxide Nasal Spray | Approved on 15.11.2021 |
| CTM/024/2021 | A randomized, double blind, placebo controlled, multi-centre, clinical trial to evaluate the efficacy in preventing the progression into severe disease & safety of oral Dipyridamole as add on therapy to standard care on clinical outcomes in hospitalized adult patients with mild & moderate covid 19 disease | Dr.A.Keerthi Pathirana | Investigator driven | Dipyridamole | Awaiting responses of the applicant to review comments (received under fast-track procedure) |
| CTM/025/2021 | Edoxaban for intracranial haemorrhage survivors with atrial fibriliiation | Dr.Bimsara Senanayake | Hamilton Health Sciences, through its population Health Research Institute, Canada | Edoxaban | Approved on 25.05.2022 |
| CTM/026/2021 | A gobal, phase 3, double blind, randomized controlled study to compare the efficacy, safety & immunogenicity of LUBT010 with Lucentis in patients with neovascular age related muscular degeneration | Dr.Charith Fonseka | Lupin Limited, Maharashtra, India | Ranibizumab | Approved on 17.05.2022 |
| Reference No. | Study title | Principal Investigator | Sponsor | Investigational Product | Status/Outcome |
| CLITRI/2020/00008 | Effectiveness of Oral Serratiopeptidase in Reduction of Lower Limb Cellulitis: A randomized controlled study | Dr. N. L. Mohotti | Investigator driven | Serratiopeptidase | Approved on 14.08.2020 |
| CLITRI/2020/00032 | Hydroxychlroquine for Post-Exposure Prophylaxis of COVID-19 among naval personnel: a placebo-controlled, randomized, clinical trial | Prof. Madunil Niriella | Investigator driven | Hydroxychlroquine | Approved on 05.05.2020 (processed under fast-track procedure) Abandoned due to noncompliance by study participants following adverse media reports on HCQ |
| CLITRI/2020/00033 | “Zafirlukast” for the treatment of Coronavirus disease (COVID-19): A Randomized double-blind placebo-controlled clinical trial – under review | Prof. P. Galappatthy | Local reaserch grant | Zafirlukast | Awaiting responses of the applicant to review comments (received under fast-track procedure) |
| CLITRI/2020/00039 | A pilot, open-label, rater-blinded, randomized, parallel-group, multi- center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of evenamide in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their stable, therapeutically active dose of a single antipsychotic medication. | Prof. Shehan Williams | Newron Pharmaceuticals SpA, Italy | Evenamide | Approved on 21.12.2020 |
| CLITRI/2020/00040 | An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with treatment-resistant schizophrenia (TRS) not responding adequately to their current antipsychotic medication | Prof. Shehan Williams | Newron Pharmaceuticals SpA, Italy | Evenamide | Approved on 21.12.2020 |
| CLITRI/2020/0041 | Effects of a combination supplement containing Lysine Vitamin C and Zinc on oxidative stress glycaemic control and formation of Advanced Glycosylation End Products in patients with type 2 diabetes mellitus A randomized double blind placebo controlled clinical tria | Dr.Ranil Jayawardana | Lysulin Inc, California, USA | Lysulin Capsules (containing L- Lysine + Zinc+Vitamin C) | Approved on 22.12.2020 |
| CLITRI/2020/0042 | Efficacy and safety of GMRx2 a single pill combination containing telmisartan amlodipine indapamide compared to dual combinations for the treatment of hypertension An international multicenter randomized double blind active controlled parallel group trial | Dr. Gotabhaya Ranasinghe | George Medicines PTY Ltd, Australia | Telmisartan/ Amlodipine/ Indapamide | Approved on 25.01.2021 |
| CLITRI/2020/0043 | A Multicenter Randomized Double Blind Placebo Controlled Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A IgA Nephropathy | Dr. Chula Herath | Approved on 08.01.2021 |
| Reference No. | Study title | Principal Investigator | Sponsor | Investigational product | Status/Outcome |
| CTM/13/18 | Efficacy & safety of oral hydroxyurea in transfusion dependent beta thalassemia: randomized double blind placebo controlled | Dr. Sachith Mettananda (University of Kelaniya) | Local research grant (NSF) | Hydroxyurea | Approved on 08.03.2019 |
| CTM/14/18 | Prophylactic dexamethasone for the prevention early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer | Dr. Umesh Jayarajah (University of Colombo) | Investigator-driven | Dexamethasone | Not approved (New application submitted with prednisolone as IMP , following review comments) |
| CTM/15/18 | Efficacy & safety of chelation therapy with calcium disodium EDTA in the progression of CKDu in Sri Lanka - A double blinded placebo controlled randomized controlled clinical trial | Dr. Eranga Wijewickrama (University of Colombo) | Local research grant (University of Colombo) | Edetate calcium disodium | Not approved(No response to review comments) |
| CTM/16/18 | Oxidative stress in CKDu and the efficacy and safety of vit C and vit E in slowing progression of early stages of CKD u in Sri Lanka – A randomized double blind placebo controlled trial | Prof. Saroj Jayasinghe (University of Colombo) | Local research grant (University of Colombo) | Vitamin C, Vitamin E | Not approved(No response to review comments) |
| CTM/17/19 | A phase III, multicenter, multi-country, open label, randomized, active controlled clinical trial to evaluate the efficacy and safety of Desisustat vs Darbepoetinfor the treatment of Anaemia in patients with CKD who are not on dialysis | Dr. A. L. M. Nazar (NHSL, Colombo) | Cadila Healthcare, India | Desidustat | Approved on 21.08.2019 |
| CTM/18/19 | Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer | Dr. Umesh Jayarajah (University of Colombo) | Investigator-driven | Prednisolone | Approved on 04.12.2019 |
| CTM/19/19 | A randomized controlled trial of the efficacy of activated charcoal in paracetamol overdose | Dr. N.K. Anjana Silva (Rajarata University) | SACTREC | Activated Charcoal | Regulatory approval not required (To proceed with ethics approval) |
| CTM/20/19 | rVA576 (Covesin) Long Term Safety and Efficacy Surveillance Study | Dr. Senani Williams | Akari Therapeutics, United Kingdom | rVA576 (a recombinant small protein) | Approved on 18.11.2019 |
| CTM/21/19 | A phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of Ataluren in patients with nonsense mutation Duchenne muscular dystrophy and open-label extension | Prof. Harendra De Silva | PTC Therapeutic Inc, USA | Ataluren | Under review |
Applicant
| Reference No. | Title | Applicant | Date of approval |
| CTM/002/2017 | A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter, Multinational Study to evaluate the efficacy and safety of TRC 150094 as an addon to standard of care in improving cardiovascular risk in subjects with diabetes, dyslipidaemia and hypertension. | Dr. Noel Somasundaram (Coordinating PI:) | 10.01.2018 |
| CTD/001/2017 | Effectiveness of Paranasal Sinus Air Suction in the Treatment of Acute Migraine Headache - A Randomized, Double-Blind, Placebo-Controlled Study |
Dr. S.M Rathnasiri Bandara (Principal Investigator) |
16.01.2018 |
| CTM/007/2017 | Efficacy and Safety of Once Weekly Thyroxine versus Daily Thyroxine as maintenance Therapy of Hypothyroidism: A Randomized, Controlled Exploratory Clinical Trial. | Dr. Uditha Bulugahapitiya (Principal Investigator) | 18.04.2018 |
| CTM/003/2017 | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Prof. Arjuna de Silva (Coordinating PI:) | 08.05.2018 |
| CTM/005/2017 | Combined Phase 3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease. | Prof. Arjuna de Silva (Coordinating PI:) | 08.05.2018 |
| CTM/008/2017 | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluating the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis. | Prof. Arjuna de Silva (Coordinating PI:) | 08.05.2018 |
| CTM/010/2018 | Effects of the Lysulin TM supplementation on pre-diabetes: a randomized double-blind, placebo-controlled clinical trial. |
Dr. M.A Ranil Jayawardena (Principal Investigator) |
05.06.2018 |
| CTM/004/2017 | A Long term extension study to evaluate the safety of Filgotinib in subjects with Ulcerative Colitis. | Prof. Arjuna de Silva (Coordinating PI:) | 06.06.2018 |
| CTM/006/2017 | A Long term extension study to evaluate the safety of Filgotinib in subjects with Crohn’s Disease. | Prof. Arjuna de Silva (Coordinating PI:) | 06.06.2018 |
| CTM/011/2018 | CAPSTONE: Phase III Confirmatory Assessment Protocol: rVA576 Safety and Efficacy in Three-Part, Two-Arm, Randomized Open Label Evaluation in Patients with Paroxymal Nocturnal Haemoglobinuria (PNH). | Dr. Senani Williams (Principal Investigator) | 03.08.2018 |
| CTM/009/2018 | The efficacy and safety of N-acetylcysteine in patients with acute kidney injury complicating leptospirosis – A randomized controlled clinical trial | Prof. Senaka Rajapakse (Principal Investigator) | 31.12.2018 |