Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity

NCT02519387 | Completed Phase 4 Results

• 1 other identifier: BUP11-MY-401
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not responding to non-opioid analgesics. The primary objective was to assess the efficacy of buprenorphine transdermal patch for pain control among these patients.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Box Scale-11 (BS-11) Pain Score

  The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported. BS-11 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.

  Baseline,3 months

Secondary Outcomes (4)

• Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)

  Baseline, 3 months

• Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage

  3 months

• Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively

  3 months

• Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events

  3 months

Study Arms (1)

Buprenorphine Transdermal Patch

EXPERIMENTAL

Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months

Drug: Buprenorphine Transdermal Patch

Interventions

Buprenorphine Transdermal Patch DRUG

Also known as: Sovenor®

Buprenorphine Transdermal Patch

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 40 years and above at the time of recruitment.
• Clinical diagnosis of osteoarthritis, rheumatoid arthritis, lower back pain or joint/muscle pain.
• Having non-malignant pain of moderate intensity requiring an opioid for adequate analgesia. This was determined using BS-11 scores, where the cut-off point is ≥4.
• Patients had to be opioid treatment naïve as defined by no opioid treatment (including tramadol, morphine etc.) in the preceding 1 month.
• Patients who have uncontrolled pain and had not responded to non-opioid analgesics for 1 month or more.
• Patients who provided informed consent.

You may not qualify if:

• Pregnant and lactating females.
• Patients with chronic condition(s), in addition to (osteoarthritis) OA, that required frequent analgesic treatment (e.g. frequent headaches, frequent migraine, and gout).
• Patients who were awaiting a scheduled operation or other surgical procedure during study period.
• Prior history of being on opioids in the preceding one month prior to the study for the management of chronic non-malignant pain.
• Patients with history of allergic reactions against paracetamol/acetaminophen, Non Steroidal Anti-Inflammatory drugs (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 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 had demonstrated behaviour that suggests a dependency or drug abuse.
• Patients who were at the time taking hypnotics or other central nervous system depressants that may pose a risk of additional central nervous system (CNS) depression with study medication.
• Patients who were at the time being administered monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks before screening.
• Patients who were at the time taking adjuvant analgesics such as anti-depressants (e.g. amitriptyline, amoxapine, clomipramine, selective serotonin re-uptake inhibitors (SSRIs)) and anticonvulsants (e.g. gabapentin, pregabalin).

Sponsors & Collaborators

• Mundipharma Pharmaceuticals Sdn. Bhd.: lead

Study Sites (3)

Hospital University Sains Malaysia

Kota Bharu, Kelantan, 10200, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

University Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

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

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: Elayne Chan
• Organization: Mundipharma Pharmaceuticals Sdn Bhd

Elayne.Chan@mundipharma.com.my

+60 122162170

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: July 15, 2015
• First Posted: August 10, 2015
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 20, 2016
• Results First Posted: July 20, 2016

Record last verified: 2016-07

Locations

MY (3)