NCT00872885

Brief Summary

The purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

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

March 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

March 24, 2009

Last Update Submit

July 13, 2021

Conditions

Post Operative Pain

Keywords

analgesicbunionectomysurgerypost operative painsingle Hallux valgus repair

Outcome Measures

Primary Outcomes (1)

  • Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments

    8 hours

Secondary Outcomes (4)

  • Amount of rescue medication

    24 hours

  • Adverse events

    24 hours

  • Time to first rescue medication

    24 hours

  • Patient Global Impression of Change

    24 hours

Study Arms (5)

A

EXPERIMENTAL

Dose 1

Drug: GRT6005

B

EXPERIMENTAL

Dose 2

Drug: GRT6005

C

EXPERIMENTAL

Dose 3

Drug: GRT6005

D

ACTIVE COMPARATOR

Morphine

Drug: Morphine

E

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GRT6005DRUG

liquid formulation, 200 to 600 µg, single dose, one day

Also known as: Morphine
ABC
MorphineDRUG

60 mg

D
PlaceboDRUG

single dosage

E

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy

You may not qualify if:

  • Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
  • Concomitant inflammatory disease.
  • Life-long history of seizure disorder or epilepsy.
  • Subjects with impaired renal function
  • Subjects with impaired hepatic function
  • Female subjects who are pregnant or breastfeeding.
  • Resting pulse rate is \<50bpm or \>100 bpm after 5 minutes rest in supine position
  • resting blood pressure after 5 minutes rest in supine position: Systolic blood pressure is \<100mmHg or \>140 mmHg Diastolic blood pressure is \<60 mmHg or \> 90 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Premier Research Group Ltd

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • John Bothmer, Dr.

    Grünenthal GmbH

    STUDY DIRECTOR

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 31, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

US(1)