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

June 2, 2009 updated by: Danube Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wiltshire
      • Chippenham, Wiltshire, United Kingdom, SN14 6NQ
        • Omnicare Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
dosage X mg BID
Drug: DNB-001
four dosages of DNB-001, one placebo dosage
Experimental: 2
dosage Y mg BID
Drug: DNB-001
four dosages of DNB-001, one placebo dosage
Experimental: 3
dosage Z mg BID
Drug: DNB-001
four dosages of DNB-001, one placebo dosage
Experimental: 4
dosage 2Z mg BID
Drug: DNB-001
four dosages of DNB-001, one placebo dosage
Placebo Comparator: 5
Placebo BID
Drug: DNB-001
four dosages of DNB-001, one placebo dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 days of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
7, 14, 21 days of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danube Pharmaceuticals, Inc.

Investigators

  • Study Chair: Barrett Katz, MD, CEO, CMO, Danube Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNB-001-CT001
  • EudoraCT 2006-003907-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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