NCT00509743

Brief Summary

The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2007

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

5 months

First QC Date

July 27, 2007

Last Update Submit

February 11, 2009

Conditions

Healthy

Keywords

Adult volunteers

Outcome Measures

Primary Outcomes (1)

  • To assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.

    24 hours

Study Arms (2)

A

EXPERIMENTAL

Low dose Diclofenac

Drug: Intravenous diclofenac sodium (DIC075V)

B

EXPERIMENTAL

High dose Diclofenac

Drug: Intravenous diclofenac sodium (DIC075V)

Interventions

Intravenous diclofenac sodium (DIC075V)DRUG

High dose Diclofenac

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult volunteers over age 18

You may not qualify if:

  • Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs or to any of the excipients of the study preparation
  • History of previous and/or present cerebral hemorrhage, peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or HIV antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Comprehensive Phase One

Miramar, Florida, 33025, United States

Location

PAREXEL International

Baltimore, Maryland, 21225, United States

Location

Study Officials

  • D. Ronald Goldwater, MD

    Parexel

    PRINCIPAL INVESTIGATOR

  • William Gerson, D.O.

    Comprehensive Phase One

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 31, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

US(2)