Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01743625
Other study ID # COV15010232
Secondary ID
Status Completed
Phase Phase 3
First received December 4, 2012
Last updated October 18, 2016
Start date November 2012
Est. completion date July 2013

Study information

Verified date October 2016
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to show the effectiveness of COV155 compared to placebo in subjects with acute moderate to severe pain following bunionectomy surgery.


Recruitment information / eligibility

Status Completed
Enrollment 406
Est. completion date July 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

- Voluntarily provide written informed consent

- General good health

- 18 to 75 years of age

- Scheduled for primary unilateral first metatarsal bunionectomy (with no collateral procedures)

- Body mass index =33

- Female subjects eligible if

- Not pregnant or lactating; not planning to become pregnant for duration of study;

- Surgically sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or practicing acceptable birth control for more than 2 months prior to Screening, during the study and for 1 week following last dose of COV155

- Male subjects must be sterile (biologically or surgically) or use reliable birth control during the study until at least 1 week after the last dose of COV155

- Classified as either Physical Status-1 (PS) or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.

- Willing to complete pain assessments and clinic visits.

- Additional inclusion criterion for randomization into the Double-Blind Phase: Subjects must experience postoperative pain intensity score =5 on a 0 to 10 Numerical Pain Rating Score (NPRS) more than 1 hour, and less than 9 hours after discontinuing the nerve block, and at least 30 minutes after the last ice pack has been removed (if used).

Exclusion Criteria

- Uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude study participation

- Clinically significant abnormal ECG at Screening

- Gastric bypass surgery or gastric band

- Previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus

- History of any medical condition that would alter the absorption, distribution, metabolism or excretion of COV155 including but not limited to severe chronic diarrhea, chronic constipation, severe irritable bowel syndrome, or unexplained weight loss

- History of severe bronchial asthma, hypercarbia, hypoxia or sleep apnea

- Certain lab abnormalities

- Addison's disease, benign prostatic hyperplasia, or kidney disease

- Donated blood or blood components within 3 months prior to Screening or during study

- Known allergy/hypersensitivity to any opioid analgesics, anesthetics, acetaminophen, non steroidal anti-inflammatory drugs (NSAIDs)

- History of intolerance to short term opioid use

- Unable to discontinue the use of prohibited medications or a history of substance or alcohol abuse within 2 years prior to Screening or a positive quantitative urine drug test at Screening

- Positive for human immunodeficiency virus, hepatitis B or C

- Dysphagia and/or cannot swallow study treatment whole

- History of migraine or frequent headaches within the previous 2 years, seizures, or are currently taking anticonvulsants

- Previously received COV155 in a clinical study, or undergone a bunionectomy within the last 3 months

- Received any investigational drugs or devices within 4 weeks prior to Screening or during study

- Active malignancy or history of malignancy within 2 years prior to Screening, other than completely eradicated cervical squamous cell carcinoma in situ or basal skin cancer

- Currently taking neuroleptics or stable doses of a benzodiazepine

- Other criteria as specified in the protocol

- Additional exclusion criterion for randomization into the Double-Blind Phase: Have surgical complications that could compromise the safety of the subject or confound the results of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
COV155
COV155 tablets
placebo


Locations

Country Name City State
United States Anaheim Clinical Trials Anaheim California
United States Chesapeake Research Group, LLC Pasadena Maryland
United States Lotus Clinical Research, LLC Pasadena California
United States Jean Brown Research, Inc. Salt Lake City Utah
United States Endeavor Clinical Trails, PA San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary SPID48 (Summed pain intensity difference) 48 hour Summed pain intensity difference 48 hours No
Secondary Safety and tolerability of COV155 Safety and tolerability to be evaluated with physical exams, vital signs, pulse oximetry, clinical laboratory tests, electrocardiograms, and adverse events 48 hours Yes
Secondary Onset of analgesia of COV155 versus placebo Onset of confirmed perceptible pain relief, time to meaningful pain relief, and time to peak pain intensity difference 48 hours No
Secondary Analgesic effects of COV155 versus placebo Pain intensity scores, pain intensity differences, and summed pain intensity differences; pain relief scores and total pain relief; percent responders; mean dosing interval; use of rescue medication; global assessment of subject satisfaction with study treatment. 48 hours No
See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2