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

March 24, 2009
June 21, 2010
March 2009
August 2009   (final data collection date for primary outcome measure)
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Sum of pain intensity 2-12 hours after Investigational medicinal product intake. Pain assessments [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00872885 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Quality of life [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Amount and first time of Rescue medication [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Adverse events, ECG, Lab [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Bunionectomy Trial With GRT6005
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.

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post Operative Pain
  • Drug: GRT6005
    liquid formulation, 200 to 600 µg, single dose, one day
    Other Name: Morphine
  • Drug: Morphine
    60 mg
  • Drug: Placebo
    single dosage
  • Experimental: A
    Dose 1
    Intervention: Drug: GRT6005
  • Experimental: B
    Dose 2
    Intervention: Drug: GRT6005
  • Experimental: C
    Dose 3
    Intervention: Drug: GRT6005
  • Active Comparator: D
    Morphine
    Intervention: Drug: Morphine
  • Placebo Comparator: E
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
October 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00872885
425965
No
Dr. Stephen E. Daniels, Premiere Research
Grünenthal GmbH
Not Provided
Study Director: John Bothmer, Dr. Grünenthal GmbH
Grünenthal GmbH
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP