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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683501
First Posted: May 23, 2008
Last Update Posted: June 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Danube Pharmaceuticals, Inc.
  Purpose
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

Condition Intervention Phase
Ocular Hypertension Elevated IOP Glaucoma Drug: DNB-001 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Danube Pharmaceuticals, Inc.:

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 [ Time Frame: 28 days of therapy ]

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 [ Time Frame: 7, 14, 21 days of therapy ]

Enrollment: 54
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683501


Locations
United Kingdom
Omnicare Clinical Research Center
Chippenham, Wiltshire, United Kingdom, SN14 6NQ
Sponsors and Collaborators
Danube Pharmaceuticals, Inc.
Investigators
Study Chair: Barrett Katz, MD CEO, CMO, Danube Pharmaceuticals, Inc.
  More Information

Responsible Party: Mr. Clive Migdal, Western Eye Hospital
ClinicalTrials.gov Identifier: NCT00683501     History of Changes
Other Study ID Numbers: DNB-001-CT001
EudoraCT 2006-003907-38
First Submitted: May 21, 2008
First Posted: May 23, 2008
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by Danube Pharmaceuticals, Inc.:
ocular hypertension
elevated IOP
glaucoma
neuroprotection

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases