RN624 For Pain Of Post-Herpetic Neuralgia
A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH POST-HERPETIC NEURALGIA
2 other identifiers
interventional
99
1 country
31
Brief Summary
This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2007
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2007
CompletedFirst Posted
Study publicly available on registry
December 6, 2007
CompletedStudy Start
First participant enrolled
December 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2009
CompletedResults Posted
Study results publicly available
May 28, 2021
CompletedMay 28, 2021
February 1, 2021
1 year
December 3, 2007
May 5, 2021
May 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6
Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.
Baseline, Week 6
Secondary Outcomes (28)
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Baseline, Week 1, 2, 4, 8, 12, 16
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16
Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16
Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16
Week 1, 2, 4, 6, 8, 12, 16
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6
Baseline, Week 6
- +23 more secondary outcomes
Other Outcomes (5)
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab
Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose
1, 2688 hours postdose on Day 1
Total Clearance of Tanezumab From Plasma
Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
- +2 more other outcomes
Study Arms (3)
1
EXPERIMENTAL2
ACTIVE COMPARATOR3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female of any race, at least 18 years of age.
- Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
- Has a pain score at screening that qualifies.
- Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
- Body Mass Index less than or equal to 39 kg/m2.
- If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
- Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Patients must consent in writing to participate in the study.
You may not qualify if:
- Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
- Disqualifying scores on questionnaires.
- Other moderate to severe pain from other conditions.
- History of allergic or anaphylactic reaction to antibodies.
- Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
- Unable to use acetaminophen.
- Disqualify laboratory values, Hepatitis B or C or HIV.
- Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
- Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
- Cancer other than basal cell or squamous cell carcinoma.
- Fails a urine test for illegal drugs including prescription drugs without a prescription.
- Plans for surgery during the study.
- History of alcoholism or drug abuse in the past two years.
- Surgery for post-herpetic neuralgia.
- Any condition that the investigator feels would put the safety of the patient at risk.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (31)
Anniston Medical Clinic/Pinnacle Research Group LLC
Anniston, Alabama, 36207, United States
Anniston Neurology & Headache Mgmt. Ctr.
Anniston, Alabama, 36207, United States
Dedicated Clinical Research, Inc.
Litchfield Park, Arizona, 85340, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Jem Research, LLC
Atlantis, Florida, 33462, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Innovative Research of West Florida, Inc.
Largo, Florida, 33770, United States
Miami Medical Associates
Miami, Florida, 33175, United States
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, 33418, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351, United States
Meridien Research
Tampa, Florida, 33606, United States
Cotton-O'Neil Clinical Research
Topeka, Kansas, 66606, United States
Cotton-O'Neil Clinic
Topeka, Kansas, 66606, United States
International Research Center
Towson, Maryland, 21286, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, 02747, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, 55435, United States
A & A Pain Institute
St Louis, Missouri, 63141, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, 28806, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45432, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, 16602, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635-0909, United States
DiscoveResearch Incorporated
Bryan, Texas, 77802, United States
Neurological Clinic of Texas
Dallas, Texas, 75230, United States
Mobley Research Center
Houston, Texas, 77024, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Jay Ellis Jr., MD-Tejas Anesthesia
San Antonio, Texas, 78229, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, 78229, United States
National Clinical Research, Incorporated
Richmond, Virginia, 23294, United States
Related Publications (1)
Bramson C, Herrmann DN, Carey W, Keller D, Brown MT, West CR, Verburg KM, Dyck PJ. Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain. Pain Med. 2015 Jun;16(6):1163-76. doi: 10.1111/pme.12677. Epub 2015 Jan 16.
PMID: 25594611DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2007
First Posted
December 6, 2007
Study Start
December 19, 2007
Primary Completion
December 20, 2008
Study Completion
January 7, 2009
Last Updated
May 28, 2021
Results First Posted
May 28, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.