Primary outcomeNumber· 15 and 30 minutes after study drug administration
Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint
| Group | Value (responders) |
|---|---|
| Cohort 2: Placebo | 1 |
| Cohort 2: CR845 0.040 mg/kg | 1 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataStudy to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
NCTNCT00877799 (opens ClinicalTrials.gov in a new tab)Other idCR845-CLIN2001
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 114 participants (actual)
- Sponsor
- Cara Therapeutics, Inc. · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Mar 2009
- Primary completion
- Dec 2009
- Completion
- Jan 2010
- First posted
- 8 Apr 2009 (estimated)
- Last update posted
- 12 May 2015 (estimated)
- Conditions
- Acute Pain
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200920102011
- Ph 2
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
NCT00877799Mar 2009 to Jan 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine the effectiveness and safety of single intravenous doses of the kappa opioid agonist CR845 in relieving pain in patients following laparoscopic-assisted hysterectomy surgery. The study protocol was divided into two parts with subjects either dosed with study drug the day following surgery (Cohort 1), or immediately after surgery (Cohort 2).
Interventions
- CR845Drug
- CR845Drug
- CR845Drug
- PlaceboDrug
- PlaceboDrug
Arms2
Experimental
CR845
CR845 administered as a single 15-min i.v. infusion at doses of 0.008 or 0.024 mg/kg on the day after surgery (Cohort 1), or at a dose of 0.040 mg/kg immediately after surgery (Cohort 2)
Placebo comparator
Placebo
Matched placebo administered as a single 15-min i.v. infusion on the day after surgery (Cohort 1), or the immediately after surgery (Cohort 2)
Primary outcomes1
Outcomes the sponsor listed as primary.
Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint
Time frame · 15 and 30 minutes after study drug administration
Registry description
The primary efficacy endpoint was the percentage of treatment responders compared to placebo. A responder was defined as a subject who had at least a 40% reduction in their pain intensity score and a pain relief score of "some," "a lot," or "complete" at 15 and 30 min following the start of the study drug infusion.
Secondary outcomes(1)
Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment
Time frame · 0 to 16 hours
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeMean· 0 to 16 hours
Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment
| Group | Value (mg) | Spread |
|---|---|---|
| Cohort 2: Placebo | 24.0 | 15.4 |
| Cohort 2: CR845 0.040 mg/kg | 15.8 | 11.8 |
Other pre specified outcomeMean· 4 to 8 hours
Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment
| Group | Value (mg) | Spread |
|---|---|---|
| Cohort 2: Placebo | 5.9 | 4.56 |
| Cohort 2: CR845 0.040 mg/kg | 2.9 | 2.63 |
Other pre specified outcomeMean· 8 to 16 hours
Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment
| Group | Value (mg) | Spread |
|---|---|---|
| Cohort 2: Placebo | 6.5 | 5.28 |
| Cohort 2: CR845 0.040 mg/kg | 13.8 | 11.5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cohort 1: PlaceboMatched placebo administered 24 hours after surgery (Day 1) | – | 2 / 25 | 17 / 25 |
| Cohort 1: CR845 0.008 mg/kgCR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1) | – | 1 / 22 | 14 / 22 |
| Cohort 1: CR845 0.024 mg/kgCR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1) | – | 2 / 21 | 18 / 21 |
| Cohort 2: PlaceboMatched Placebo administered within 3 hours after surgery (Day 0) | – | 1 / 26 | 14 / 26 |
| Cohort 2: CR845 0.040 mg/kgCohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0) | – | 3 / 20 | 12 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 21 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* The patients will have an elective laparoscopic-assisted hysterectomy under general anesthesia.
* The patient's preoperative health is graded as the American Society of Anesthesiologists (ASA) risk class of I to III
Exclusion Criteria:
* The patient has a history of known allergies to opioids
* The patient is currently taking opioid analgesics chronically or took opioid analgesics on at least 4 days during the week before surgery.
* Patients having additional procedures (such as those involving the bladder) at the same time as the laparoscopic-assisted hysterectomy.
* Patients taking short-acting oral analgesics (eg, acetaminophen, aspirin, ibuprofen, ketorolac) within 6 hours before administration of study drug; long-acting nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, naproxen, oxaprozin, piroxicam, celecoxib) within 3 days before administration of study drug; systemic steroids within 72 hours before administration of study drug; or any opioid analgesics or tramadol daily for greater than 10 days of the last 30 days before administration of study drug.
* Patients taking the following herbal agents or nutraceuticals within 7 days prior to beginning of the study: chaparral, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian.
* Patients with clinically significant cardiovascular disease, or cardiac arrhythmias, or significant major risk factors for cardiovascular disease such as poorly controlled hypertension, poorly controlled hypercholesterolemia, poorly controlled diabetes mellitus or serious medical conditions, such as cancer.
* Patient has a history of hepatitis B or C or HIV infection with positive hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody test.
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