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Bunionectomy Trial With GRT6005

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872885
First Posted: March 31, 2009
Last Update Posted: July 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Grünenthal GmbH
  Purpose
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).

Condition Intervention Phase
Post Operative Pain Drug: GRT6005 Drug: Morphine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Moderate to Severe Pain Following Bunionectomy.

Resource links provided by NLM:


Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments [ Time Frame: 8 hours ]

Secondary Outcome Measures:
  • Amount of rescue medication [ Time Frame: 24 hours ]
  • Adverse events [ Time Frame: 24 hours ]
    Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values

  • Time to first rescue medication [ Time Frame: 24 hours ]
  • Patient Global Impression of Change [ Time Frame: 24 hours ]

Enrollment: 258
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dose 1
Drug: GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
Other Name: Morphine
Experimental: B
Dose 2
Drug: GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
Other Name: Morphine
Experimental: C
Dose 3
Drug: GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
Other Name: Morphine
Active Comparator: D
Morphine
Drug: Morphine
60 mg
Placebo Comparator: E
Placebo
Drug: Placebo
single dosage

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872885


Locations
United States, Texas
Premier Research Group Ltd
Austin, Texas, United States, 78705
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Study Director: John Bothmer, Dr. Grünenthal GmbH
  More Information

Responsible Party: Dr. Stephen E. Daniels, Premiere Research
ClinicalTrials.gov Identifier: NCT00872885     History of Changes
Other Study ID Numbers: 425965
First Submitted: March 24, 2009
First Posted: March 31, 2009
Last Update Posted: July 19, 2010
Last Verified: June 2010

Keywords provided by Grünenthal GmbH:
analgesic
bunionectomy
surgery
post operative pain
single Hallux valgus repair

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents