Safety, Efficacy, and Pharmacokinetic Profile of DNB-001... | NCT00683501

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

NCT00683501

Sponsor

Danube Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Jun 3, 2009Estimated

Enrollment

54Actual

Phase

Phase 1Phase 2

Conditions

Ocular Hypertension
Elevated IOP
Glaucoma

Interventions

DNB-001

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudoraCT 2006-003907-38

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

May 21, 2008

First Submission Date that Met QC Criteria

May 22, 2008

First Posted Date

May 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2009

Last Update Posted Date

Jun 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	dosage X mg BID	Drug: DNB-001
2	Experimental	dosage Y mg BID	Drug: DNB-001
3	Experimental	dosage Z mg BID	Drug: DNB-001
4	Experimental	dosage 2Z mg BID	Drug: DNB-001
5	Placebo Comparator	Placebo BID	Drug: DNB-001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNB-001	Drug	four dosages of DNB-001, one placebo dosage	1 2 3 4 5

Outcomes Module

Primary Outcomes

Measure	Description	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		28 days of therapy

Secondary Outcomes

Measure	Description	Time Frame
Percentage change and responder rates - e.g., > 20% reduction in lOP values from baseline to Day 21, Day 14 and Day 7		7, 14, 21 days of therapy

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barrett Katz, MD	CEO, CMO, Danube Pharmaceuticals, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Omnicare Clinical Research Center		Chippenham	Wiltshire	SN14 6NQ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009798	Ocular Hypertension
D005901	Glaucoma

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided