A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids (Hydro/Lido)

NCT02689856 Phase 2 COMPLETED

The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride or hydrocortisone acetate found in many prescription hemorrhoid products.

Details

Lead sponsor	Citius Pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	211
Start date	2015-05
Completion	2015-10

Conditions

• Hemorrhoids

Interventions

• Hydrocortisone acetate and lidocaine hydrochloride
• Placebo control
• Hydrocortisone acetate
• Lidocaine hydrochloride

Primary outcomes

• Global score of disease severity — up to 14 days
  A measure overall discomfort on a scale of 0 to 5