Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain

NCT01961271 | Completed Phase 4 Results

• 1 other identifier: BUP12-AP-401
• Study Type: interventional
• Target: 114
• Locations: 3 countries
• Sites: 16

Brief Summary

The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, who are not adequately responding to non-opioid painkillers.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Lower Back Pain; Joint Pain; Muscle Pain

Keywords

Norspan; buprenorphine; transdermal; patch; chronic pain; non-malignant; osteoarthritis; rheumatoid arthritis; lower back pain; joint pain; muscle pain; opioid; analgesic; painkiller; Mundipharma

Outcome Measures

Primary Outcomes (1)

• Efficacy According to BS-11 Pain Score Reduction

  The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score. BS-11 is known as "Box scale-11"; it is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time.

  Maximum 17 weeks starting from enrolment

Secondary Outcomes (5)

• Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention

  approximately 17 weeks starting from enrolment

• Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE

  From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)

• Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication

  Approximately 17 weeks starting from enrolment

• Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively

  At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)

• Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.

  From time of enrolment to Visit 6 (ie. up to119 days from enrolment)

Study Arms (1)

Buprenorphine transdermal patch

EXPERIMENTAL

Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.

Drug: Buprenorphine transdermal patch

Interventions

Buprenorphine transdermal patch DRUG

Please see Arm Description.

Also known as: Norspan transdermal patch, Sovenor transdermal patch

Buprenorphine transdermal patch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18-80 years (both inclusive) at the time of recruitment.
• Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint / muscle pain.
• Having non-malignant pain of moderate or severe intensity requiring an opioid for adequate analgesia (according to local label of Norspan® or Sovenor®). This is to be determined using BS-11 scores, where the cut-off point is ≥4.
• Patients with chronic uncontrolled pain and is assessed to require opioid treatment but have not been treated with opioids (including tramadol, morphine etc.) within 4 weeks or more before study entry.

You may not qualify if:

• Pregnant and lactating females.
• Patients with chronic condition(s), in addition to osteoarthritis, that require(s) frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
• Patients who are awaiting a scheduled operation or other surgical procedure during study period or 3 months or less post-operative.
• Prior history of being on opioids in the preceding 1 month prior to the study for the management of chronic non-malignant pain.
• Prior history of buprenorphine transdermal system use.
• Patients with history of allergic reactions against paracetamol/ acetaminophen, NSAIDs and/or opioids.
• Patients with allergies or other contraindications to transdermal systems or patch adhesives.
• Patients with dermatological disorders who may have problems applying patch or rotating patch placement area.
• Patients with cancer (except for basal cell carcinoma) or history of cancer who have been diagnosed within five years prior to the first study visit (except for treated basal cell carcinoma).
• Patients with conditions such as brain tumour, brain injury or raised intracranial pressure.
• Patients with history of psychiatric disorder, uncontrollable epilepsy, untreated depression or other psychiatric disorders of a type that would make participation in the study an unacceptable risk to the patient.
• Patients with any conditions causing poor cognitive function as assessed by the participating physician.
• Patients with history of alcohol and drug abuse or patients who have demonstrated behaviour that suggests a dependency or drug abuse.
• Patients currently taking hypnotics or other central nervous system depressants that may pose a risk of additional central nervous system depression with study medication.
• Patients who are currently being administered monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks before screening.

Sponsors & Collaborators

• Mundipharma Pte Ltd.: lead
• Mundipharma Korea Ltd: collaborator
• Mundipharma (Hong Kong) Ltd: collaborator
• Mundipharma Distribution GmBH (Philippine Branch): collaborator

Study Sites (16)

Pok Oi Hospital

Yuen Long, New Territories, Hong Kong

Location

Queen Elizabeth Hospital

Gascoigne Road, Hong Kong

Location

Queen Mary Hospital (Dept of Anaesthesiology)

Pokfulam Road, Hong Kong

Location

Queen Mary Hospital (Dept of Rheumatology)

Pokfulam Road, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Tuen Mun Hospital

Tuenmen, Hong Kong

Location

Makati Medical Center

Makati City, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

University of Santo Tomas Hospital

Manila, Philippines

Location

St. Luke's Medical Center

Quezon City, Philippines

Location

Samsung Medical Center

Gangnam-Gu, Seoul, 135710, South Korea

Location

Seoul National University Hospital (Dept of Neurology)

Jongno-gu, Seoul, 110744, South Korea

Location

Seoul National University Hospital (Dept of Orthopedics)

Jongno-gu, Seoul, 110744, South Korea

Location

Seoul St. Mary's Hospital

Seocho-gu, Seoul, 137701, South Korea

Location

Severance Hospital

Seodaemun-gu, Seoul, 120752, South Korea

Location

Asan Medical Center

Songpa-Gu, Seoul, 138736, South Korea

Location

Related Publications (1)

• Yoon DH, Bin SI, Chan SK, Chung CK, In Y, Kim H, Lichauco JJ, Mok CC, Moon YW, Ng TK, Penserga EG, Shin DA, You D, Moon H. Effectiveness and tolerability of transdermal buprenorphine patches: a multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain. BMC Musculoskelet Disord. 2017 Aug 4;18(1):337. doi: 10.1186/s12891-017-1664-4.

  PMID: 28778219 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Low Back Pain; Arthralgia; Myalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Results Point of Contact

• Title: Valerie Anne Leck
• Organization: Mundipharma Pte Ltd

info.rma@mundipharma.com.sg

+65 6511 1165

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 11, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 23, 2016
• Results First Posted: September 23, 2016

Record last verified: 2016-08

Locations

HK (6); PH (4); KR (6)