A Study to assess the safety and efficacy of FDC of Propranolol Hydrochloride IP Plus Clonazepam IP Tablets in patients with anxiety disorders.

Not Applicable

Recruiting

• Conditions: Generalized anxiety disorder,

• Registration Number: CTRI/2020/07/026634
• Lead Sponsor: Akums Drugs Pharmaceuticals Limited

Brief Summary

**A post marketing, multicentre, single-arm, prospective clinical trial to assess the safety and efficacy of FDC of PROPRANOLOL HYDROCHLORIDE IP + CLONAZEPAM IP Tablets in patients with anxiety disorders.â€**

**Primary Objective**

To assess the safety of FDC PROPRANOLOL HYDROCHLORIDE IP 10MG / 10MG / 20MG / 20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG / 0.5MG Tablets in patients with anxiety disorders

**Secondary Objective**

To assess the efficacy of FDC PROPRANOLOL HYDROCHLORIDE IP 10MG / 10MG / 20MG /20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG / 0.5MG Tablets in patients with anxiety disorders.



**Investigational  product**

Fixed dose combination (FDC) of PROPRANOLOL HYDROCHLORIDE IP IP 10MG / 10MG / 20MG /20MG + CLONAZEPAM IP 0.25MG / 0.5MG / 0.25MG /0.5MG Tablets

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-31
• Last Update Posted: 2023-02-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1. Male or female patients age 18.
• 65 years. 2. Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohavenapproved board-eligible psychiatrist; The duration of illness must be ≥ 1 year 3. Hamilton Anxiety Scale (HAM-A) score at least 14. 4. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed. 5. Literate and can understand and sign informed consent. 6. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline.

Exclusion Criteria

• Pregnant and lactating female patients.
• Hypersensitivity and/or skin reactions to drug constituents 3.
• Patients with congestive heart failure 4.
• Patients with bronchospastic lung disease, or severe respiratory insufficiency 5.
• Patients planned to be undergoing any major surgery 6.
• Patients with diabetes and specifically prone to hypoglycaemia 7.
• Patients with a history of hypothyroidism 8.
• Wolf-Parkinson-White Syndrome and tachycardia 9.
• Patients with impaired hepatic or renal function 10.
• Patients with sleep apnoea, myasthenia gravis and narrow-angle glaucoma.
• Patients using any of the prohibited medications: a) Opioids) Use of alcohol/CNS depressants c) Antiepileptic drugs phenytoin, phenobarbital, carbamazepine, lamotrigine and valproate d) drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways e) Cardiovascular drugs: antiarrhythmics, Digitalis Glycosides, Calcium Channel Blockers, ACE Inhibitors, Alpha Blockers, Reserpine, inotropic agents, Isoproterenol and Dobutamine, f) Nonsteroidal Anti-Inflammatory Drugs, Antidepressants, Anesthetic Agents, Warfarin, Neuroleptic Drugs, Thyroxine.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants who experienced at least one adverse event (AE)	Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6
•Proportion of discontinuations due to AEs	Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6
•Incidence of Serious AEs	Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6
•Changes in the laboratory parameters from baseline to the end of treatment.	Day 1/Week 1; Day 15±2/ Week 3; Day 42±2/ Week 6

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Severity Scale (CGI-S)	Clinical Global Impression-Anxiety Scale (CGI-anxiety)

Trial Locations

Locations (10)

Maharaja Agrasen Hospital; 🇮🇳 West, DELHI, India

Abhinav Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Dr. Ram Manohar Lohia Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Excel Hospital; 🇮🇳 Hyderabad, TELANGANA, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Healthpoint Multispeciality Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Institute of Medical Sciences & Sum Hospital; 🇮🇳 Khordha, ORISSA, India

Krishna Institute of Medical Sciences; 🇮🇳 Hyderabad, TELANGANA, India

Om Sai Onco Surgery Center; 🇮🇳 Kolhapur, MAHARASHTRA, India

Tulsi Hospital India Limited; 🇮🇳 Nagar, UTTAR PRADESH, India

Maharaja Agrasen Hospital

🇮🇳West, DELHI, India

Dr Nitant Singhal

Principal investigator

9868220809

nitantsinghal1@gmail.com