PMZ-2010 (Centhaquine) as a Resuscitative Agent for Hypovolemic Shock

• Status: Completed
• Trial end date: 2018-10-21
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-II efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock.

Centhaquine is highly safe and well tolerated. Toxicological studies showed high safety margin in preclinical studies. Its safety and tolerability has been demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647; NCT02408731).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmazz, Inc.

Criteria

Inclusion Criteria:

• Adult males or females aged 18-70 years.

• Patients with Hypovolemic shock due to blood loss admitted to the emergency room or ICU with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the patients shall be the one used in the particular hospital setup.

• Body weight 45 kg - 85 kg.

• Female subject is either: (1) Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or, (2) If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, or A vasectomised partner OR abstinence.

Exclusion Criteria:

• Terminal illness

• Development of any other terminal illness not associated with Hypovolemic shock due to blood loss during the 28 day observation period

• Patient with severe brain injury or with a Glasgow Coma Scale (GCS) < 8

• Type of injury is not known

• Inability to obtain intravenous access

• Known pregnancy

• Cardiopulmonary resuscitation (CPR) before randomization

• Presence of a do not resuscitate order

• Patient taking beta adrenergic antagonists

• Untreated tension pneumothorax

• Untreated cardiac tamponade

• Bilateral absent pupillary light reflex (both pupils fixed and dilated)

• Patient is participating in another interventional study

• Patients with systemic diseases which were already present before having trauma, such as: cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS