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

Sponsored by:	Danube Pharmaceuticals, Inc.
Information provided by:	Danube Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00683501

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 I Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 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 ]

Estimated Enrollment:	60
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dosage X mg BID	Drug: DNB-001 four dosages of DNB-001, one placebo dosage
2: Experimental dosage Y mg BID	Drug: DNB-001 four dosages of DNB-001, one placebo dosage
3: Experimental dosage Z mg BID	Drug: DNB-001 four dosages of DNB-001, one placebo dosage
4: Experimental dosage 2Z mg BID	Drug: DNB-001 four dosages of DNB-001, one placebo dosage
5: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683501

Contacts

Contact: Barrett Katz, MD	646 375 4641	bk@danubepharma.com
Contact: Yordak Salermo, MA	646 375 4636	ys@danubepharma.com

Locations

United Kingdom, Wiltshire
Omnicare Clinical Research Center	Recruiting
Chippenham, Wiltshire, United Kingdom, SN14 6NQ
Contact: Clive Migdal, MD 44 (0) 20 7886 3258 jan.burkett@St-Marys.nhs.uk
Principal Investigator: Yogesh Patwala, MD
Principal Investigator: Augusto Azura-Blanco, MD
Principal Investigator: Anthony King, MD
Principal Investigator: Phillip Bloom, MD

Sponsors and Collaborators

Danube Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Western Eye Hospital ( Mr. Clive Migdal )
Study ID Numbers:	DNB-001-CT001, EudoraCT 2006-003907-38
Study First Received:	May 21, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00683501 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Danube Pharmaceuticals, Inc.:

ocular hypertension
elevated IOP
glaucoma
neuroprotection

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Vascular Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Vascular Diseases

Cardiovascular Diseases
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009