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Trial record 27 of 666 for:    OXYCODONE

Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

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ClinicalTrials.gov Identifier: NCT01369615
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : January 15, 2015
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Oxycodone hydrochloride controlled-release tablets
Enrollment 23
Recruitment Details First Patient First Visit: 05-January-2012; Last Patient Last Visit: 09-December-2013. The study was conducted at 14 medical/research sites in the United States and Israel.
Pre-assignment Details Opioid-experienced pediatric patients with moderate to severe malignant and/or nonmalignant pain requiring around-the-clock opioid therapy were eligible for open-label Extension Study OTR3002 if they completed the 4-week treatment period Core Study OTR3001 and could benefit from continued treatment with oxycodone HCl CR 20 to 240 mg total daily.
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description Children 6 to < 12 years of age Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
Period Title: Overall Study
Started 9 14
Completed 9 12
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             0             1
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years Total
Hide Arm/Group Description Children 6 to < 12 years of age Children 12 to ≤ 16 years of age Total of all reporting groups
Overall Number of Baseline Participants 9 14 23
Hide Baseline Analysis Population Description
The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 14 participants 23 participants
9.9  (1.76) 14.3  (1.49) 12.6  (2.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 14 participants 23 participants
Female
6
  66.7%
7
  50.0%
13
  56.5%
Male
3
  33.3%
7
  50.0%
10
  43.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 14 participants 23 participants
White 6 10 16
Black or African American 3 4 7
1.Primary Outcome
Title The Number of Participants With Adverse Events as a Measure of Safety.
Hide Description Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.
Time Frame Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
Hide Outcome Measure Data
Hide Analysis Population Description
The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description:
Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
Overall Number of Participants Analyzed 9 14
Measure Type: Number
Unit of Measure: participants
Serious adverse events 3 2
All other adverse events in ≥ 5% of patients 8 8
Time Frame Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
Adverse Event Reporting Description AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
 
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description Children 6 to < 12 years of age Children ≥ 12 to ≤ 16 years of age
All-Cause Mortality
6 to < 12 Years ≥ 12 to ≤ 16 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
6 to < 12 Years ≥ 12 to ≤ 16 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   3/9 (33.33%)   2/14 (14.29%) 
Congenital, familial and genetic disorders     
Sickle cell anaemia with crisis  1  1/9 (11.11%)  1/14 (7.14%) 
Gastrointestinal disorders     
Constipation  1  1/9 (11.11%)  0/14 (0.00%) 
Vomiting  1  0/9 (0.00%)  1/14 (7.14%) 
General disorders     
Pyrexia  1  1/9 (11.11%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/9 (0.00%)  1/14 (7.14%) 
Nervous system disorders     
Headache  1  0/9 (0.00%)  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
6 to < 12 Years ≥ 12 to ≤ 16 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   8/9 (88.89%)   8/14 (57.14%) 
Blood and lymphatic system disorders     
Anaemia  1  1/9 (11.11%)  0/14 (0.00%) 
Lymphadenopathy  1  1/9 (11.11%)  0/14 (0.00%) 
Congenital, familial and genetic disorders     
Sickle cell anaemia with crisis  1  0/9 (0.00%)  1/14 (7.14%) 
Ear and labyrinth disorders     
Auricular swelling  1  0/9 (0.00%)  1/14 (7.14%) 
External ear pain  1  1/9 (11.11%)  0/14 (0.00%) 
Eye disorders     
Conjunctivitis  1  1/9 (11.11%)  0/14 (0.00%) 
Eye pain  1  1/9 (11.11%)  0/14 (0.00%) 
Mydriasis  1  1/9 (11.11%)  0/14 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  2/9 (22.22%)  2/14 (14.29%) 
Constipation  1  1/9 (11.11%)  1/14 (7.14%) 
Nausea  1  1/9 (11.11%)  1/14 (7.14%) 
Abdominal pain  1  0/9 (0.00%)  1/14 (7.14%) 
Diarrhoea  1  0/9 (0.00%)  1/14 (7.14%) 
Oral pain  1  1/9 (11.11%)  0/14 (0.00%) 
Stomatitis  1  1/9 (11.11%)  0/14 (0.00%) 
General disorders     
Pyrexia  1  3/9 (33.33%)  2/14 (14.29%) 
Adverse drug reaction  1  0/9 (0.00%)  1/14 (7.14%) 
Cyst  1  0/9 (0.00%)  1/14 (7.14%) 
Fatigue  1  1/9 (11.11%)  0/14 (0.00%) 
Inflammation  1  0/9 (0.00%)  1/14 (7.14%) 
Mucosal inflammation  1  1/9 (11.11%)  0/14 (0.00%) 
Pain  1  1/9 (11.11%)  0/14 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/9 (11.11%)  0/14 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  0/9 (0.00%)  1/14 (7.14%) 
Oral candidiasis  1  1/9 (11.11%)  0/14 (0.00%) 
Sinusitis  1  0/9 (0.00%)  1/14 (7.14%) 
Urinary tract infection  1  1/9 (11.11%)  0/14 (0.00%) 
Vaginal infection  1  0/9 (0.00%)  1/14 (7.14%) 
Investigations     
Haemoglobin decreased  1  1/9 (11.11%)  1/14 (7.14%) 
Platelet count decreased  1  1/9 (11.11%)  1/14 (7.14%) 
Blood bilirubin increased  1  0/9 (0.00%)  1/14 (7.14%) 
Blood magnesium decreased  1  1/9 (11.11%)  0/14 (0.00%) 
Neutrophil count decreased  1  0/9 (0.00%)  1/14 (7.14%) 
Oxygen saturation decreased  1  1/9 (11.11%)  0/14 (0.00%) 
Respiratory rate  1  1/9 (11.11%)  0/14 (0.00%) 
Transaminases increased  1  1/9 (11.11%)  0/14 (0.00%) 
Weight decreased  1  0/9 (0.00%)  1/14 (7.14%) 
White blood cell count decreased  1  0/9 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders     
Dehydration  1  1/9 (11.11%)  0/14 (0.00%) 
Hypocalcaemia  1  1/9 (11.11%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/9 (0.00%)  1/14 (7.14%) 
Pain in extremity  1  1/9 (11.11%)  0/14 (0.00%) 
Nervous system disorders     
Headache  1  1/9 (11.11%)  0/14 (0.00%) 
Sedation  1  1/9 (11.11%)  0/14 (0.00%) 
Somnolence  1  1/9 (11.11%)  0/14 (0.00%) 
Psychiatric disorders     
Depression  1  0/9 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/9 (11.11%)  1/14 (7.14%) 
Epistaxis  1  2/9 (22.22%)  0/14 (0.00%) 
Atelectasis  1  1/9 (11.11%)  0/14 (0.00%) 
Respiratory depression  1  1/9 (11.11%)  0/14 (0.00%) 
Respiratory distress  1  0/9 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  0/9 (0.00%)  1/14 (7.14%) 
Photosensitivity reaction  1  0/9 (0.00%)  1/14 (7.14%) 
Pruritus  1  1/9 (11.11%)  0/14 (0.00%) 
Rash  1  1/9 (11.11%)  0/14 (0.00%) 
Scar  1  1/9 (11.11%)  0/14 (0.00%) 
Seborrhoea  1  0/9 (0.00%)  1/14 (7.14%) 
Skin ulcer  1  0/9 (0.00%)  1/14 (7.14%) 
Surgical and medical procedures     
Scar excision  1  0/9 (0.00%)  1/14 (7.14%) 
Vascular disorders     
Flushing  1  0/9 (0.00%)  1/14 (7.14%) 
Hypertension  1  0/9 (0.00%)  1/14 (7.14%) 
Hypotension  1  1/9 (11.11%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)

Enrollment for study OTR3002 was closed by Purdue Pharma L.P. on 01-January-2014 due to administrative reasons not related to safety.

Interpretation is limited by the small number of patients in each age group in this study.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Layout table for additonal information
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01369615     History of Changes
Other Study ID Numbers: OTR3002
2011-002235-26 ( EudraCT Number )
First Submitted: June 7, 2011
First Posted: June 9, 2011
Results First Submitted: January 7, 2015
Results First Posted: January 15, 2015
Last Update Posted: September 9, 2015