A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (NEPTUNE-17)

December 5, 2023 updated by: GlaxoSmithKline

A Multicenter Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Target Engagement of GSK3858279 in Adult Participants With Chronic Diabetic Peripheral Neuropathic Pain (DPNP) /NEPTUNE-17

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Shu
        • Contact:
        • Contact:
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Elliott
    • Manitoba
      • Winnepeg, Manitoba, Canada, R3C 0N2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vincent Woo
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Harpreet Bajaj
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vera Bril
  • China
      • Beijing, China, 100032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mingxia Yuan
      • Guangzhou, China, 510000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaoming Xue
      • Harbin, China, 150001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • ZhiFeng Cheng
      • Luoyang, China, 471003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongwei Jiang
      • Shanghai, China, 200032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Xiaoying Li
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xuefeng Yu
    • Hunan
      • Yueyang, Hunan, China, 414000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaoyue Wang
  • France
      • Angers cedex 9, France, 49933
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid Allix
      • Corbeil-Essonnes, France, 91100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alfred Penfornis
      • Maubeuge, France, 59600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mihaela Muresan
      • Mulhouse, France, 68100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liviu Serb
  • Germany
    • Bayern
      • Wallerfing, Bayern, Germany, 94574
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josef Grosskopf
    • Hessen
      • Bad Homburg, Hessen, Germany, 61348
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irma Schoell
    • Nordrhein-Westfalen
      • Muenster, Nordrhein-Westfalen, Germany, 48145
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ludger Rose
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Pfuetzner
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bernhard Schmitt
  • Japan
      • Chiba, Japan, 260-0804
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hidenori Ishida
      • Fukuoka, Japan, 807-8556
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yosuke Okada
      • Ibaraki, Japan, 300-0028
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryuji Koyama
      • Osaka, Japan, 565-0853
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Satoshi Inoue
        • Contact:
        • Contact:
      • Tochigi, Japan, 321-0204
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hisamoto Kuroda
      • Tochigi, Japan, 321-0974
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ken Tomotsune
      • Tochigi, Japan, 322-8550
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mihoko Matsumura
      • Tokyo, Japan, 103-0027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arihiro Kiyosue
      • Tokyo, Japan, 104-0031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yasushi Fukushima
      • Tokyo, Japan, 160-0008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Osamu Matsuoka
        • Contact:
        • Contact:
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35233
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Hwa Hong
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byung-Wan Lee
      • Seoul, Korea, Republic of
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaemyung Yu
      • Seoul, Korea, Republic of, 136-705
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sin Gon Kim
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Seung-Hwan Lee
        • Contact:
        • Contact:
  • Poland
      • Katowice, Poland, 40-081
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Siegel
      • Katowice, Poland, 40-282
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ilona Palka-Kisielowska
        • Contact:
        • Contact:
      • Katowice, Poland, 40-648
        • Not yet recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Danuta Wronska
        • Contact:
        • Contact:
      • Sochaczew, Poland, 96-500
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Malgorzata Fengler-Czeczko
      • Warszawa, Poland, 02-117
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ewa Pankowska
  • South Africa
      • Bellville, South Africa, 7530
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria M Pretorius
      • Somerset West, South Africa, 7130
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dorothea Vera Urbach
      • Stanger, South Africa, 4450
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Deenadayalan Pillay
      • Umkomaas, South Africa, 4170
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Trevenesan Padayachee
    • Gauteng
      • Lenasia, Gauteng, South Africa, 1827
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hemant Makan
      • Pretoria, Gauteng, South Africa, 0184
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sonja Conradie
  • Spain
      • Alzira/Valencia, Spain, 46600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos Trescoli Serrano
      • Barcelona, Spain, 08023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Beatriz Chavarría Cano
      • La Coruña, Spain, 15006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alfonso Soto Gonzalez
      • Málaga, Spain, 29010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Tinahones Madueno
      • Palma de Mallorca, Spain, 07120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elena Mena Ribas
      • Pozuelo De Alarcón. Madrid., Spain, 28223
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esteban Jodar Gimeno
      • San Sebastian de los Reyes, Spain, 28702
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jos Antonio Balsa Barro
      • Torrevieja, Spain, 3186
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julio Blazquez Encinar
  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey, 06230
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ersin Tan
    • Atasehir
      • Istanbul, Atasehir, Turkey, 34758
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kayihan Uluc
    • Balcova
      • Izmir, Balcova, Turkey, 35330
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ihsan Sukru Sengun
    • Konyaalti
      • Antalya, Konyaalti, Turkey, 07070
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramazan Sari
    • Nilüfer
      • Bursa, Nilüfer, Turkey, 16240
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Necdet Karli
    • Pamukkale
      • Denizli, Pamukkale, Turkey, 20160
        • Not yet recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cagdas Erdogan
  • United Kingdom
      • Leeds, United Kingdom, LS10 1DU
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sharon Viner
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Uazman Alam
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Prashanth Vas
      • Teesside, United Kingdom, TS17 6EW
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sharon Viner
      • Wrexham, United Kingdom, LL13 7YP
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Orod Osanlou
    • Staffordshire
      • Cannock, Staffordshire, United Kingdom, WS11 0BN
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sharon Viner
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Almena L Free
    • Arizona
      • Surprise, Arizona, United States, 85378
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raghav Mohindra
    • California
      • Lomita, California, United States, 90717
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marina Raikhel
      • Tustin, California, United States, 92780
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Kim
    • Florida
      • Miami, Florida, United States, 33135
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark E. Kutner
      • Miami, Florida, United States, 33175
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lazaro D Nunez
        • Contact:
        • Contact:
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Barry S Horowitz
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas J Schnitzer
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David DiBenedetto
        • Contact:
        • Contact:
    • New York
      • Williamsville, New York, United States, 14221
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paresh Dandona
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Binit Shah
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Aziz Shaibani
        • Contact:
        • Contact:
      • McAllen, Texas, United States, 78501
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joseph Caporusso
        • Contact:
        • Contact:
      • Red Oak, Texas, United States, 75154
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haresh Boghara
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nazia Rahman
      • Renton, Washington, United States, 98057
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ronald L. Brazg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
  • Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
  • A pain score ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10) for average daily pain intensity over the past 24 hours at the screening visit.
  • Body mass index (BMI) within the range 18-40 kilogram per meter square (kg/m^2) (inclusive)
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
  • Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia).
  • History of significant allergies to monoclonal antibodies.
  • Current enrolment or past participation in a clinical study of an investigational medicinal product intervention within the last 30 days or 5 half-lives (whichever is longer) of signing consent.
  • Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits, inability to complete the eDiary daily etc.) and/or otherwise considered by the Investigator to be unlikely to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo.
Drug: Placebo
Placebo will be administered
Experimental: GSK3858279 Dose 1
Participants will receive GSK3858279 dose 1.
Drug: GSK3858279
GSK3858279 will be administered
Experimental: GSK3858279 Dose 2
Participants will receive GSK3858279 dose 2.
Drug: GSK3858279
GSK3858279 will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the Numeric Rating Scale (NRS)
Time Frame: Baseline and Week 12
Brief Pain Inventory item 5 is a single item designed to capture information on the self-reported average pain intensity over the past 24 hours. Participants will be asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK3858279
Time Frame: At Week 12
Ctau predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
Time Frame: At Week 12
AUC(0-tau) predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
Occurrences of adverse events (AEs), serious AE (SAEs), and AEs of special interest (AESI)
Time Frame: Up to 27 weeks
AEs, SAEs, and AESIs will be collected. Any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Injection site reactions.
Up to 27 weeks
Change from Baseline in Haematology Parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, white blood cell (WBC), and platelet count (Giga cells per liter)
Time Frame: Baseline and up to Week 27
Baseline and up to Week 27
Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter)
Time Frame: Baseline and up to Week 27
Baseline and up to Week 27
Change from baseline in haematology parameter: Haemoglobin (Hb) (Grams per liter)
Time Frame: Baseline and up to Week 27
Baseline and up to Week 27
Change from baseline in haematology parameter: Haematocrit (Proportion of red blood cells in blood)
Time Frame: Baseline and up to Week 27
Baseline and up to Week 27
Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), and Alkaline Phosphatase (AP) (International units per liter)
Time Frame: Baseline and up to Week 27
Baseline and up to Week 27
Change from baseline in clinical chemistry parameter: Total bilirubin (Micromoles per liter)
Time Frame: Baseline and up to Week 27
Baseline and up to Week 27
Number of participants with greater than or equal to (≥) grade 3 hematological/clinical chemistry abnormalities according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)
Time Frame: Up to 27 weeks
Hematological/clinical chemistry abnormalities summarized according to NCI CTCAE grade
Up to 27 weeks
Maximum concentration (Cmax) of GSK3858279
Time Frame: At Week 12
Cmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
The time required for GSK3858279 to reach Cmax (tmax) in the plasma
Time Frame: At Week 12
Tmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
Average concentration over a dosing interval (Cavg) of GSK3858279
Time Frame: At Week 12
GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
At Week 12
Change from baseline in the Short-Form McGill Pain Questionnaire total score over time
Time Frame: Baseline and up to Week 12
The McGill pain questionnaire Short Form 2 is a 22-item questionnaire total score, which evaluates multi-dimensional pain over time. The questionnaire consists of 22 descriptors that are rated on an intensity scale from 0 = none to 10 = worse possible
Baseline and up to Week 12
Change from baseline in the weekly average of. average daily pain intensity over time, assessed on the NRS
Time Frame: Baseline and up to Week 12
Brief Pain Inventory item 5 is a single item designed to capture information on the self-reported average pain intensity over the past 24 hours. Participants will be asked to mark. their pain intensity on a daily basis, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.
Baseline and up to Week 12
Number of participants with greater than or equal to (≥) 30 percentage (%) reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS
Time Frame: At Week 12
To capture information on the self-reported weekly average daily pain intensity. Participants will be asked to mark their pain-intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.
At Week 12
Number of participants with greater than or equal to ≥ 50 % reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS
Time Frame: At Week 12
To capture information on the self-reported weekly average daily pain intensity. Participants will be asked to mark their pain-intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.
At Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

March 11, 2025

Study Completion (Estimated)

June 24, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214221
  • 2022-502313-28-00 (Other Identifier: EU-CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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