Trial Outcomes & Findings for 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) (NCT NCT01063868)

Last Updated: 2014-03-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

47 participants

Primary outcome timeframe

Entire Study

Results posted on

2014-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Tapentadol ER Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks	Oxycodone CR Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Overall Study STARTED	35	12
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	35	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Tapentadol ER Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks	Oxycodone CR Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Overall Study Adverse Event	9	7
Overall Study Withdrawal by Subject	3	1
Overall Study Study Terminated By Sponsor	23	4

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tapentadol ER n=35 Participants Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks	Oxycodone CR n=12 Participants Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	9 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	57.5 years STANDARD_DEVIATION 12.41 • n=5 Participants	60.1 years STANDARD_DEVIATION 9.23 • n=7 Participants	58.2 years STANDARD_DEVIATION 11.64 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	2 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Region Enroll (United States of America)	35 participants n=5 Participants	12 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Entire Study

Population: Safety analysis set (All randomized participants who took at least one dose of study medication).

Outcome measures

Outcome measures
Measure	Tapentadol ER n=35 Participants Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks	Oxycodone CR n=12 Participants Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Number of Subjects With Treatment-emergent Adverse Events (TEAE)	23 participants	11 participants

Adverse Events

Tapentadol ER

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Oxycodone CR

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Director, Clinical Leader

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phone: 609-730-4537

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Tapentadol ER n=35 participants at risk Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks	Oxycodone CR n=12 participants at risk Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Musculoskeletal and connective tissue disorders Arthralgia	5.7% 2/35 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.	0.00% 0/12 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.
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/35 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.	8.3% 1/12 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.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/35 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.	8.3% 1/12 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.
Skin and subcutaneous tissue disorders Pruritus	5.7% 2/35 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.	25.0% 3/12 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.9% 1/35 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.	8.3% 1/12 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.
Infections and infestations Upper respiratory tract infection	5.7% 2/35 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.	0.00% 0/12 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.
Metabolism and nutrition disorders Decreased appetite	2.9% 1/35 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.	8.3% 1/12 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.
Gastrointestinal disorders Nausea	20.0% 7/35 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.	50.0% 6/12 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.
Gastrointestinal disorders Dry mouth	8.6% 3/35 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.	8.3% 1/12 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.
Gastrointestinal disorders Constipation	5.7% 2/35 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.	25.0% 3/12 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.
Gastrointestinal disorders Diarrhoea	5.7% 2/35 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.	0.00% 0/12 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.
Gastrointestinal disorders Vomiting	2.9% 1/35 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.	16.7% 2/12 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/35 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.	16.7% 2/12 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.
Nervous system disorders Somnolence	8.6% 3/35 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.	25.0% 3/12 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.
Nervous system disorders Dizziness	2.9% 1/35 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.	8.3% 1/12 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.
Nervous system disorders Headache	2.9% 1/35 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.	25.0% 3/12 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.
Psychiatric disorders Anxiety	5.7% 2/35 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.	8.3% 1/12 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.
Psychiatric disorders Confusional state	5.7% 2/35 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.	0.00% 0/12 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.
Psychiatric disorders Insomnia	5.7% 2/35 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.	0.00% 0/12 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.
Psychiatric disorders Abnormal dreams	0.00% 0/35 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.	8.3% 1/12 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.
Psychiatric disorders Depression	0.00% 0/35 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.	8.3% 1/12 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.
Psychiatric disorders Euphoric mood	0.00% 0/35 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.	8.3% 1/12 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.
Psychiatric disorders Mood swings	0.00% 0/35 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.	8.3% 1/12 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.
General disorders Fatigue	8.6% 3/35 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.	16.7% 2/12 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.
General disorders Asthenia	0.00% 0/35 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.	8.3% 1/12 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.