Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Citius Pharmaceuticals, Inc.
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Lidocaine

Criteria

Inclusion Criteria:

1. Subject is male or non-pregnant female 18 years of age or older, in generally good health. Females must be post-menopausal, surgically sterile or have a negative urine pregnancy test (UPT) at the Baseline Visit and agree to use birth control during the study.

2. Subject has provided written and verbal informed consent.

3. Subject presents to the clinic with clinically confirmed symptomatic Grade I or II hemorrhoids (GSDS ≥ 2).

4. Subject is willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

1. Subject is female and lactating or planning to become pregnant during the study.

2. Subject has anorectal condition(s) such as malignant tumors of the anus or rectum, fistula-in-ano or chronic sepsis, fissure-in-ano, incontinence, condylomata and Grade III and IV hemorrhoids.

3. Subject has a history of previous proctological surgery or has active inflammatory bowel disease.

4. Subject may use stool softeners, but shall be on a stable regimen for at least 28 days prior to enrolling in the study.

5. Subject used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:

• Within 1 day: Topicals of any kind to the rectal/peri-rectal area.

• Within 1 week: Over the counter (OTC) or prescription treatments labeled or intended for the treatment of hemorrhoids or that could have a significant effect in the opinion of the investigator including but not limited to steroids, OTC and prescription hemorrhoid products, among others.

6. Subject has a current history of an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin or non-steroidals).

7. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical, systemic or surgical therapy.

8. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.

9. Subject has any condition which, in the Investigator's opinion, would make it unsafe or preclude the subject's ability to fully participate in this research study.

10. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function or physical limitations.

11. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.

12. Subject is currently enrolled in an investigational drug or device study.

13. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).