NCT00390312

Brief Summary

This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for phase_2 postoperative-pain

Timeline
Completed

Started Sep 2001

Shorter than P25 for phase_2 postoperative-pain

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

Study Start

First participant enrolled

September 1, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
Last Updated

January 4, 2008

Status Verified

December 1, 2007

Enrollment Period

2 months

First QC Date

October 17, 2006

Last Update Submit

December 28, 2007

Conditions

Post-Operative PainThird Molar Extraction

Keywords

Post operative painThird molar extractionDental surgeryMorphine

Outcome Measures

Primary Outcomes (1)

  • Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours

    2 hours

Secondary Outcomes (1)

  • Other measures of pain relief

    Several time points

Study Arms (7)

4

ACTIVE COMPARATOR

Intravenous morphine

Drug: Intravenous morphine

1

EXPERIMENTAL

Intranasal morphine 7.5 mg

Drug: Intranasal morphine 7.5 mg

2

EXPERIMENTAL

Intranasal morphine 15 mg

Drug: Intranasal Morphine 15 mg

3

ACTIVE COMPARATOR

Oral morphine 60 mg

Drug: Immediate Release Oral Morphine 60 mg

5

PLACEBO COMPARATOR

Intranasal placebo

Drug: Intranasal Placebo

6

PLACEBO COMPARATOR

Oral placebo

Drug: Oral placebo

7

PLACEBO COMPARATOR

Intravenous placebo

Drug: Intravenous placebo

Interventions

Intranasal PlaceboDRUG

Intranasal placebo

5
Intranasal Morphine 15 mgDRUG

Intranasal Morphine 15 mg

2
Immediate Release Oral Morphine 60 mgDRUG

Immediate Release Oral Morphine 60 mg

3
Intravenous morphineDRUG

Intravenous morphine 7.5 mg

4
Intranasal morphine 7.5 mgDRUG

Intranasal morphine 7.5 mg

1
Oral placeboDRUG

Oral placebo

6
Intravenous placeboDRUG

Intravenous placebo

7

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female 18-40 years of age
  • Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
  • Moderate or severe pain within 6 hours of completion of surgery

You may not qualify if:

  • Other oral surgical procedures during the same session except the removal of supernumerary third molars
  • Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
  • Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
  • Allergy to shellfish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Kyle Christensen, DDS

    Jean Brown Associates, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

September 1, 2001

Primary Completion

November 1, 2001

Study Completion

November 1, 2001

Last Updated

January 4, 2008

Record last verified: 2007-12