NCT00520104

Brief Summary

This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 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 29, 2008

Status Verified

August 1, 2007

Enrollment Period

6 months

First QC Date

August 21, 2007

Last Update Submit

February 27, 2008

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    multiple

Study Arms (3)

A

EXPERIMENTAL

intranasal ketamine

Drug: intranasal ketamine

B

EXPERIMENTAL

oxymetazoline plus intranasal ketamine

Drug: intranasal ketamine

C

EXPERIMENTAL

intranasal steroid plus intranasal ketamine

Drug: intranasal ketamine

Interventions

intranasal ketamineDRUG

drug interaction

ABC

Eligibility Criteria

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

You may qualify if:

  • Healthy adults
  • Patients with Allergic Rhinitis

You may not qualify if:

  • Under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javelin Pharmaceuticals

Cambridge, Massachusetts, 02140, United States

Location

Study Officials

  • Javelin Pharmaceuticals

    Javelin Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

February 29, 2008

Record last verified: 2007-08

Locations

US(1)