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A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01063868
Recruitment Status : Terminated (Business decision)
First Posted : February 5, 2010
Results First Posted : May 10, 2011
Last Update Posted : March 4, 2014
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetic Neuropathy, Painful
Diabetic Polyneuropathy
Interventions Drug: Tapentadol extended release (ER)
Drug: Oxycodone controlled release (CR)
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tapentadol ER Oxycodone CR
Hide Arm/Group Description Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Period Title: Overall Study
Started 35 12
Completed 0 0
Not Completed 35 12
Reason Not Completed
Adverse Event             9             7
Withdrawal by Subject             3             1
Study Terminated By Sponsor             23             4
Arm/Group Title Tapentadol ER Oxycodone CR Total
Hide Arm/Group Description Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks Total of all reporting groups
Overall Number of Baseline Participants 35 12 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 12 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  74.3%
9
  75.0%
35
  74.5%
>=65 years
9
  25.7%
3
  25.0%
12
  25.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 12 participants 47 participants
57.5  (12.41) 60.1  (9.23) 58.2  (11.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 12 participants 47 participants
Female
15
  42.9%
2
  16.7%
17
  36.2%
Male
20
  57.1%
10
  83.3%
30
  63.8%
Region Enroll (United States of America)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 12 participants 47 participants
35 12 47
1.Primary Outcome
Title Number of Subjects With Treatment-emergent Adverse Events (TEAE)
Hide Description The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Time Frame Entire Study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (All randomized participants who took at least one dose of study medication).
Arm/Group Title Tapentadol ER Oxycodone CR
Hide Arm/Group Description:
Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Overall Number of Participants Analyzed 35 12
Measure Type: Number
Unit of Measure: participants
23 11
Time Frame [Not Specified]
Adverse Event Reporting Description Only participants who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total number of participants with Non-Serious Adverse Events.
 
Arm/Group Title Tapentadol ER Oxycodone CR
Hide Arm/Group Description Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
All-Cause Mortality
Tapentadol ER Oxycodone CR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tapentadol ER Oxycodone CR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tapentadol ER Oxycodone CR
Affected / at Risk (%) Affected / at Risk (%)
Total   19/35 (54.29%)   11/12 (91.67%) 
Gastrointestinal disorders     
Nausea * 1  7/35 (20.00%)  6/12 (50.00%) 
Dry mouth * 1  3/35 (8.57%)  1/12 (8.33%) 
Constipation * 1  2/35 (5.71%)  3/12 (25.00%) 
Diarrhoea * 1  2/35 (5.71%)  0/12 (0.00%) 
Vomiting * 1  1/35 (2.86%)  2/12 (16.67%) 
Abdominal pain * 1  0/35 (0.00%)  2/12 (16.67%) 
General disorders     
Fatigue * 1  3/35 (8.57%)  2/12 (16.67%) 
Asthenia * 1  0/35 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Upper respiratory tract infection * 1  2/35 (5.71%)  0/12 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/35 (2.86%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/35 (5.71%)  0/12 (0.00%) 
Back pain * 1  1/35 (2.86%)  1/12 (8.33%) 
Myalgia * 1  0/35 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Somnolence * 1  3/35 (8.57%)  3/12 (25.00%) 
Dizziness * 1  1/35 (2.86%)  1/12 (8.33%) 
Headache * 1  1/35 (2.86%)  3/12 (25.00%) 
Psychiatric disorders     
Anxiety * 1  2/35 (5.71%)  1/12 (8.33%) 
Confusional state * 1  2/35 (5.71%)  0/12 (0.00%) 
Insomnia * 1  2/35 (5.71%)  0/12 (0.00%) 
Abnormal dreams * 1  0/35 (0.00%)  1/12 (8.33%) 
Depression * 1  0/35 (0.00%)  1/12 (8.33%) 
Euphoric mood * 1  0/35 (0.00%)  1/12 (8.33%) 
Mood swings * 1  0/35 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  2/35 (5.71%)  3/12 (25.00%) 
Hyperhidrosis * 1  1/35 (2.86%)  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Early termination, due to sponsor's discretion, lead to only 47 patients out of the 800 planned (5.9%) being available for analysis. The data should be interpreted with caution.
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: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 609-730-4537
Layout table for additonal information
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01063868    
Other Study ID Numbers: CR016978
R331333PAI3028 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
KF57 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Submitted: February 4, 2010
First Posted: February 5, 2010
Results First Submitted: April 14, 2011
Results First Posted: May 10, 2011
Last Update Posted: March 4, 2014