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Trial record 1 of 1 for:    NCT00872885
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Bunionectomy Trial With GRT6005

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ClinicalTrials.gov Identifier: NCT00872885
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Tris Pharma, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: GRT6005 Drug: Morphine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
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.
Study Start Date : March 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. Amount of rescue medication [ Time Frame: 24 hours ]
  2. 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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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United States, Texas
Premier Research Group Ltd
Austin, Texas, United States, 78705
Sponsors and Collaborators
Tris Pharma, Inc.
Investigators
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Study Director: John Bothmer, Dr. Grünenthal GmbH
More Information
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Responsible Party: Tris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00872885    
Other Study ID Numbers: 425965
KF5503/37 ( Other Identifier: Sponsor )
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Keywords provided by Tris Pharma, Inc.:
analgesic
bunionectomy
surgery
post operative pain
single Hallux valgus repair
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents