NCT01298297

Brief Summary

The purpose of this study is to determine whether sublingual buprenorphine is effective in the treatment of acute pain in adult patients with extremity bone fractures

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

February 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

February 15, 2011

Last Update Submit

December 6, 2012

Conditions

Acute Pain

Keywords

Buprenorphine, acute pain, analgesia

Outcome Measures

Primary Outcomes (1)

  • Change in pain severity/score

    After 60 min

Secondary Outcomes (2)

  • Need for rescue analgesia

    After 60 min

  • Occurrence of adverse events

    During 60 min

Study Arms (2)

Buprenorphine + Placebo

ACTIVE COMPARATOR
Drug: Buprenorphine

Morphine + Placebo

PLACEBO COMPARATOR
Drug: Morphine

Interventions

BuprenorphineDRUG

0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)

Buprenorphine + Placebo
MorphineDRUG

Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV

Morphine + Placebo

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of extremity bone fracture Age\>16 years Acute pain of score 3 or greater on numerical rating scale

You may not qualify if:

  • Long term use of opium or opioids/dependence Previous administration of analgesic Known sensitivity to opioids Pregnant women History of medical problems (liver, kidney, heart, hematologic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Imam Hospital

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Acute PainAgnosia

Interventions

BuprenorphineMorphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsMorphine Derivatives

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 17, 2011

Study Start

February 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

IR(1)