HealthyPhase 1DFC-PK-008NCT00509743

Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium

A Phase 1 study testing Intravenous diclofenac sodium (DIC075V) in people with Healthy, run by Javelin Pharmaceuticals at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Intravenous diclofenac sodium (DIC075V)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 2 sitesUnited States
Study dates: Sep 2007to Mar 2008
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult volunteers over age 18

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

PAREXEL International
Baltimore, Maryland, 21225
Comprehensive Phase One
Miramar, Florida, 33025

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study 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

Read the detailed description

This study is an open label, single center, single-dose study 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. This study will be conducted in two cohorts. The first cohort of subjects will be selected based on body mass index (BMI) and weight criteria. The second cohort of subjects will be selected based on age.

Conditions: Healthy
Being tested: Intravenous diclofenac sodium (DIC075V)
Keywords: Adult volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous diclofenac sodium (DIC075V)Drug
High dose Diclofenac
Intravenous diclofenac sodium (DIC075V)Drug
Low Dose Diclofenac

Study groups in NCT00509743
Study group	Role	What they receive
A	Experimental	Low dose Diclofenac Receives: Drug: Intravenous diclofenac sodium (DIC075V)
B	Experimental	High dose Diclofenac Receives: Drug: Intravenous diclofenac sodium (DIC075V)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Mar 2008

First posted31 Jul 2007 (estimated)
Study startSep 2007
Primary completionFeb 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 89 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00509743
Sponsor's protocol ID: DFC-PK-008
Acronym: DFC-PK-008
Status last verified: Feb 2009
First submitted: 27 Jul 2007
Last updated: 12 Feb 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study 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
ClinicalTrials.gov ID: NCT00509743
Acronym / sponsor ID: DFC-PK-008 / DFC-PK-008
Conditions: Healthy
Keywords: Adult volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (estimated)
Lead sponsor: Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Feb 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 31 Jul 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Intravenous diclofenac sodium (DIC075V)Low dose Diclofenac
B	Experimental	Drug: Intravenous diclofenac sodium (DIC075V)High dose Diclofenac

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult volunteers over age 18

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravenous diclofenac sodium (DIC075V)High dose Diclofenac	Drug	B
Intravenous diclofenac sodium (DIC075V)Low Dose Diclofenac	Drug	A

Primary outcome

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.
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

D. Ronald Goldwater, MD principal investigator

Parexel

William Gerson, D.O. principal investigator

Comprehensive Phase One

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intravenous diclofenac sodium (DIC075V) in people with Healthy, run by Javelin Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00509743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2009.