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

This study has been completed.
Sponsor:
Information provided by:
Danube Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00683501
First received: May 21, 2008
Last updated: June 2, 2009
Last verified: June 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 21, 2008
Last Updated: June 2, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on August 18, 2014