Back to results

Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure (DNB-001)

Primary Purpose

Ocular Hypertension, Elevated IOP, Glaucoma

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

DNB-001

About this trial

This is an interventional treatment trial for Ocular Hypertension focused on measuring ocular hypertension, elevated IOP, glaucoma, neuroprotection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (IOP), with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/50 or better in each eye and lOP of 21 to 29 mm Hg at baseline.

Exclusion Criteria:

Use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma
Evidence of potential angle closure by gonioscopy
Abnormal optic disc or visual field consistent with glaucoma
Use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.

Sites / Locations

Omnicare Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

dosage X mg BID

dosage Y mg BID

dosage Z mg BID

dosage 2Z mg BID

Placebo BID

Outcomes

Primary Outcome Measures

The reduction of IOP as calculated on the basis of the arithmetic mean of up to six measurements of IOP, comparing baseline to visit 6

Secondary Outcome Measures

Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7

Full Information

NCT ID

NCT00683501

First Posted

May 21, 2008

Last Updated

June 2, 2009

Sponsor

Danube Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00683501

Brief Title

Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure

Acronym

DNB-001

Official Title

A Phase II Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients With Elevated Intraocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Danube Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients with intraocular Hypertension

Detailed Description

To evaluate the efficacy of four dosages of mg DNB-001 administered twice daily (bid) per os (p.o.) as an anti-ocular hypertensive agent, compared with placebo administered bid po, for 28 days, in patients with ocular hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Hypertension, Elevated IOP, Glaucoma

Keywords

ocular hypertension, elevated IOP, glaucoma, neuroprotection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

dosage X mg BID

Arm Title

Arm Type

Experimental

Arm Description

dosage Y mg BID

Arm Title

Arm Type

Experimental

Arm Description

dosage Z mg BID

Arm Title

Arm Type

Experimental

Arm Description

dosage 2Z mg BID

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo BID

Intervention Type

Drug

Intervention Name(s)

DNB-001

Intervention Description

four dosages of DNB-001, one placebo dosage

Primary Outcome Measure Information:

Title

The reduction of IOP as calculated on the basis of the arithmetic mean of up to six measurements of IOP, comparing baseline to visit 6

Time Frame

28 days of therapy

Secondary Outcome Measure Information:

Title

Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7

Time Frame

7, 14, 21 days of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (IOP), with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/50 or better in each eye and lOP of 21 to 29 mm Hg at baseline. Exclusion Criteria: Use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma Evidence of potential angle closure by gonioscopy Abnormal optic disc or visual field consistent with glaucoma Use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barrett Katz, MD

Organizational Affiliation

CEO, CMO, Danube Pharmaceuticals, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Omnicare Clinical Research Center

City

Chippenham

State/Province

Wiltshire

ZIP/Postal Code

SN14 6NQ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure

We'll reach out to this number within 24 hrs