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Bunionectomy Trial With GRT6005

This study has been completed.
Sponsor:
Information provided by:
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT00872885
First received: March 24, 2009
Last updated: June 21, 2010
Last verified: June 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of rescue medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Stephen E. Daniels, Premiere Research
ClinicalTrials.gov Identifier: NCT00872885     History of Changes
Other Study ID Numbers: 425965
Study First Received: March 24, 2009
Last Updated: June 21, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013