Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

NCT ID: NCT00635609

Last Updated: 2012-04-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-09-30

Brief Summary

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Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Detailed Description

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Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxycycline hyclate (Doryx)

Group Type EXPERIMENTAL

Doxycycline hyclate (Doryx)

Intervention Type DRUG

150mg/day, oral, delayed release tablets

Doxycycline hyclate

Group Type ACTIVE_COMPARATOR

Doxycycline hyclate

Intervention Type DRUG

100 mg/day, oral, tablets, immediate release

Interventions

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Doxycycline hyclate (Doryx)

150mg/day, oral, delayed release tablets

Intervention Type DRUG

Doxycycline hyclate

100 mg/day, oral, tablets, immediate release

Intervention Type DRUG

Other Intervention Names

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Doryx

Eligibility Criteria

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Inclusion Criteria

* Must be 12 years of age or older.
* Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.

Exclusion Criteria

* Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
* Has a history of pseudomembranous colitis or antibiotic-associated colitis.
* Has a history of hepatitis or liver damage or renal impairment.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angelo Secci, MD

Role: STUDY_DIRECTOR

Warner Chilcott

Locations

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Warner Chilcott Investigational Site

Vista, California, United States

Site Status

Warner Chilcott Investigational Site

Miami, Florida, United States

Site Status

Warner Chilcott Investigational Site

Louisville, Kentucky, United States

Site Status

Warner Chilcott Investigational Site

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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PR-08607

Identifier Type: -

Identifier Source: org_study_id

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