Post Operative PainPhase 2NCT00872885
Bunionectomy Trial With GRT6005
A Phase 2 study testing GRT6005 and Morphine in people with Post Operative Pain, run by Tris Pharma, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- GRT6005 and Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Conditions
- Post Operative Pain
- Being tested
- GRT6005, Morphine, Placebo
- Keywords
- analgesic, bunionectomy, surgery, post operative pain, single Hallux valgus repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT6005Drug
Also called Morphine
liquid formulation, 200 to 600 µg, single dose, one day
MorphineDrug
60 mg
PlaceboDrug
single dosage
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dose 1 Receives: Drug: GRT6005 |
| B | Experimental | Dose 2 Receives: Drug: GRT6005 |
| C | Experimental | Dose 3 Receives: Drug: GRT6005 |
| D | Active comparator | Morphine Receives: Drug: Morphine |
| E | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
Measured: 8 hours
Secondary outcomes (4)
Amount of rescue medication
Measured: 24 hours
Adverse events
Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values
Measured: 24 hours
Time to first rescue medication
Measured: 24 hours
Patient Global Impression of Change
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Bothmer, Dr., Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872885
- Sponsor's protocol ID
- 425965
- Other IDs
- KF5503/37
- Status last verified
- Jul 2021
- First submitted
- 24 Mar 2009
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00872885
- Acronym / sponsor ID
- 425965
- Conditions
- Post Operative Pain
- Keywords
- analgesic, bunionectomy, surgery, post operative pain, single Hallux valgus repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GRT6005Dose 1 |
| B | Experimental | Drug: GRT6005Dose 2 |
| C | Experimental | Drug: GRT6005Dose 3 |
| D | Active comparator | Drug: MorphineMorphine |
| E | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRT6005Also: Morphineliquid formulation, 200 to 600 µg, single dose, one day | Drug | A, B, C |
| Morphine60 mg | Drug | D |
| Placebosingle dosage | Drug | E |
Primary outcome
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
Time frame: 8 hours
4 secondary outcomes
Amount of rescue medication
Time frame: 24 hours
Adverse events
Time frame: 24 hours
Time to first rescue medication
Time frame: 24 hours
Patient Global Impression of Change
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Bothmer, Dr. study director
Grünenthal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRT6005 and Morphine in people with Post Operative Pain, run by Tris Pharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.