Pain, PostoperativePhase 2NCT01015235
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
A Phase 2 study testing KAI-1678 and Ketorolac Tromethamine in people with Pain, Postoperative, run by KAI Pharmaceuticals at 1 site in New Zealand.
Trial summary
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- KAI-1678 and Ketorolac Tromethamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteNew Zealand
- Study dates
- Dec 2008to Feb 2010
- 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
- American Society of Anesthesiologist (ASA) classification 1, 2, or 3
- total hip or total knee replacement
- pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)
Who cannot join
- presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
- recent history of angina or myocardial infarction (MI)
- clinically significant abnormality on laboratory tests or electrocardiogram (ECG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.
- Conditions
- Pain, Postoperative
- Being tested
- Placebo, KAI-1678, Ketorolac Tromethamine
- Keywords
- Ketorolac / therapeutic use, Analgesics. Non-narcotic / therapeutic use, Arthroplasty, replacement hip, Arthroplasty, replacement knee, Pain measurement / drug effect, Pain postoperative / drug therapy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subcutaneous infusion-once over 4 hours
KAI-1678Drug
Also called Active drug
Subcutaneous infusion-once over 4 hours
Ketorolac TromethamineDrug
Also called Ketorolac
Active comparator, IV infusion, once
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| A2: KAI-1678 | Active comparator | Test Drug Receives: Drug: KAI-1678 |
| A3: Ketorolac | Active comparator | Active Comparator Receives: Drug: Ketorolac Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
Measured: Post operative Day 1
Secondary outcomes (4)
The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)
Measured: Post operative Day 1
The effect of KAI-1678 on pain intensity difference (PID) at 4 hours
Measured: Post-operative Day 1
The effect of KAI-1678 on total quality analgesia
Measured: Post-operative Day 1
The effect of KAI-1678 on time to meaningful pain relief
Measured: Post-operative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- KAI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trident Clinical Research Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Gregory Bell, MD, Study director, KAI Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015235
- Sponsor's protocol ID
- KAI-1678-002
- Status last verified
- Aug 2011
- First submitted
- 16 Nov 2009
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion for the Treatment of Postoperative Pain
- ClinicalTrials.gov ID
- NCT01015235
- Acronym / sponsor ID
- KAI-1678-002
- Conditions
- Pain, Postoperative
- Keywords
- Ketorolac / therapeutic use, Analgesics. Non-narcotic / therapeutic use, Arthroplasty, replacement hip, Arthroplasty, replacement knee, Pain measurement / drug effect, Pain postoperative / drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- KAI PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Trident Clinical Research Pty Ltd
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Nov 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 this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| A2: KAI-1678 | Active comparator | Drug: KAI-1678Test Drug |
| A3: Ketorolac | Active comparator | Drug: Ketorolac TromethamineActive Comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist (ASA) classification 1, 2, or 3
- total hip or total knee replacement
- pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)
Key exclusion criteria (3 listed)
- presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
- recent history of angina or myocardial infarction (MI)
- clinically significant abnormality on laboratory tests or electrocardiogram (ECG)
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 |
|---|---|---|
| PlaceboSubcutaneous infusion-once over 4 hours | Drug | Arm 1: Placebo |
| KAI-1678Also: Active drugSubcutaneous infusion-once over 4 hours | Drug | A2: KAI-1678 |
| Ketorolac TromethamineAlso: KetorolacActive comparator, IV infusion, once | Drug | A3: Ketorolac |
Primary outcome
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4).
Time frame: Post operative Day 1
4 secondary outcomes
The effect of KAI-1678 on total pain relief over 4 hours (TOTPAR 4)
Time frame: Post operative Day 1
The effect of KAI-1678 on pain intensity difference (PID) at 4 hours
Time frame: Post-operative Day 1
The effect of KAI-1678 on total quality analgesia
Time frame: Post-operative Day 1
The effect of KAI-1678 on time to meaningful pain relief
Time frame: Post-operative Day 1
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 2 Sep 2011.
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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.
Gregory Bell, MD study director
KAI Pharmaceuticals
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 KAI-1678 and Ketorolac Tromethamine in people with Pain, Postoperative, run by KAI Pharmaceuticals at 1 site in New Zealand.
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 3 inclusion and 3 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 2 Sep 2011. 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 New Zealand. 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?
The effect of KAI-1678 on summed pain intensity difference over 4 hours (SPID 4). (time frame: Post operative Day 1). 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 2 Sep 2011.