clinical Study to Evaluate the Efficacy and Safety of test drug in comparison to reference drug in the Treatment of the patients with Hypokalemia.â??

Phase 3

Completed

• Conditions: Health Condition 1: E898- Other postprocedural endocrine andmetabolic complications and disorders

• Registration Number: CTRI/2021/01/030486
• Lead Sponsor: The ACME LaboratoriesLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-20
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Ages 18 to 65 years (both gender inclusive)

2. Patient on the investigating unit found mild to moderate serum potassium level.

(Mild hypokalemia is a serum level of 3.0 to 3.4 mEq/L, Moderate hypokalemia is a serum level of 2.5-2.9 mEq/L, and severe hypokalemia is a level of less than 2.5 mEq/L.)

Ability to take oral tablets.

Normal renal function test.

Diagnostic Criteria:

ï??Diagnosed by physician and concluded the need of electrolyte (potassium) supplementation.

ï??Increased potassium loss

-Drugs induced hypokalemia: diuretics (thiazides, loop diuretics), laxatives, glucocorticoids, fludrocortisone, penicillins, amphotericin, aminoglycosides etc.

-GI losses: diarrhoea, vomiting, ileostomy, intestinal fistula

-Renal causes:dialysis

-Endocrine disorders: hyperaldosteronism (Connâ??s syndrome), Cushingâ??s syndrome

Trans-cellular shift

-Insulin/glucose therapy

-Salbutamol and other beta-agonists

-Theophylline

-Metabolic alkalosis

Decreased potassium intake

Magnesium depletion (associated with increased renal potassium loss)

3. Ethical / legal considerations:

All the patients are willing to obtain written informed consent, according to national regulations.

Exclusion Criteria

1.Patients with a serum potassium < 2.5 mEq/L and > 3.5 mEq/L.

2.Patients with serum renal dysfunction with urine output <500ml/day or serum creatinine >2 mg/dL.

3.Hypomagnesaemia (<= 0.7mmol/L), however patients may be enrolled after the hypomagnesaemia is corrected.

4.Evidence of Intrinsic source of potassium release includes acute rhabdomyolysis, Hemolytic anemia, and tumor lysis.

5.Magnesium level < 1.5 mg/dL.

6.Use of any investigational drug currently or within 30 days prior to study entry.

7.Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.

8.Patients on any prescription medication that might interfere with study outcomes as decided by investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Adherence to a potassium level 4.0 - 4.5mmol/L <br/ ><br>2.Mean changes in serum potassium in mEq/L per each 10 mEq/L of potassium administration. <br/ ><br>Timepoint: 7 days

Secondary Outcome Measures

Name	Time	Method
1.Total quantity of potassium administered [Time Frame: 7 days] <br/ ><br>2.Incidence of potassium level 3.0mmol/L and 5.5mmol/L [Time Frame: 7 days] <br/ ><br>3.Tolerance [Visit II â??Visit VII EOT] (Attachment no. 1) <br/ ><br>4.Self-Assessment of General Health [Visit II â??Visit VII EOT] (Attachment no. 2) <br/ ><br> Assessment of safety of investigational product: <br/ ><br>Timepoint: 7 Days