Trial Outcomes & Findings for Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain (NCT NCT00594516)

Last Updated: 2015-04-15

Results Overview

For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

117 participants

Primary outcome timeframe

14 days for each cross-over period

Results posted on

2015-04-15

Participant Flow

The first site opened on 30 November 2007. The recruitment period for this outpatient, multicenter study occurred between 10 December 2007 and 01 May 2008.

The study consisted of screening period (up to 21 days), washout period (from 3 to 7 days), open label (OL) treatment period (3 weeks), followed by a double blind (DB) active treatment period, with crossover design of 2 randomized sequences of tapentadol immediate release (IR) to tapentadol extended release (ER) and tapentadol ER to IR (4 weeks)

Participant milestones

Participant milestones
Measure	Tapentadol Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period	Tapentadol IR to ER Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase	Tapentadol ER to IR Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
Open Label (OL): Tapentadol IR STARTED	116	0	0
Open Label (OL): Tapentadol IR COMPLETED	87	0	0
Open Label (OL): Tapentadol IR NOT COMPLETED	29	0	0
DB: Tapentadol IR to ER & ER to IR STARTED	0	44	43
DB: Tapentadol IR to ER & ER to IR COMPLETED	0	37	35
DB: Tapentadol IR to ER & ER to IR NOT COMPLETED	0	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Tapentadol Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period	Tapentadol IR to ER Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase	Tapentadol ER to IR Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
Open Label (OL): Tapentadol IR Withdrawal by Subject	4	0	0
Open Label (OL): Tapentadol IR Lost to Follow-up	2	0	0
Open Label (OL): Tapentadol IR Adverse Event	16	0	0
Open Label (OL): Tapentadol IR Lack of Efficacy	1	0	0
Open Label (OL): Tapentadol IR Study Medication Non Compliant	6	0	0
DB: Tapentadol IR to ER & ER to IR Withdrawal by Subject	0	3	3
DB: Tapentadol IR to ER & ER to IR Study Medication Non compliant	0	3	2
DB: Tapentadol IR to ER & ER to IR Lack of Efficacy	0	1	1
DB: Tapentadol IR to ER & ER to IR Adverse Event	0	0	2

Baseline Characteristics

Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tapentadol n=116 Participants Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=93 Participants
Age, Categorical >=65 years	30 Participants n=93 Participants
Age, Continuous	53.6 years STANDARD_DEVIATION 15.46 • n=93 Participants
Sex: Female, Male Female	65 Participants n=93 Participants
Sex: Female, Male Male	51 Participants n=93 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=93 Participants
Race/Ethnicity, Customized Asian	0 participants n=93 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants
Race/Ethnicity, Customized Black or African American	14 participants n=93 Participants
Race/Ethnicity, Customized White	90 participants n=93 Participants
Race/Ethnicity, Customized Hispanic or Latino	12 participants n=93 Participants
Race/Ethnicity, Customized Other	0 participants n=93 Participants

PRIMARY outcome

Timeframe: 14 days for each cross-over period

Population: Per-protocol set defined as the number of randomized subjects who took at least one dose of study drug during the DB treatment period, and who met additional criteria which were identified prior to unblinding.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)	0.1 Units on a scale Interval -0.09 to 0.28

SECONDARY outcome

Timeframe: 14 days for each cross-over period

Population: DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.

Outcome measures

Outcome measures
Measure	Tapentadol n=81 Participants Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment	24 participants

SECONDARY outcome

Timeframe: 14 days for each cross-over period

Population: DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.

Outcome measures

Outcome measures
Measure	Tapentadol n=84 Participants Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment	29 participants

SECONDARY outcome

Timeframe: 14-day for each DB treatment period

Population: DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.

Average total daily dose (TDD) of tapentadol IR during the double blind treatment period

Outcome measures

Outcome measures
Measure	Tapentadol n=81 Participants Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period	331.0 mg Standard Deviation 116.17

SECONDARY outcome

Timeframe: 14 days for each treatment period

Population: DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.

Average total daily dose (TDD) of tapentadol ER during the double-blind treatment period.

Outcome measures

Outcome measures
Measure	Tapentadol n=84 Participants Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.	330.4 mg Standard Deviation 123.73

Adverse Events

Tapentadol

Serious events: 2 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tapentadol n=116 participants at risk Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
Musculoskeletal and connective tissue disorders Back Pain	0.86% 1/116 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Hip Fracture	0.86% 1/116 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.

Other adverse events

Other adverse events
Measure	Tapentadol n=116 participants at risk Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
Nervous system disorders Dizziness	24.1% 28/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Nervous system disorders Headache	16.4% 19/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Nervous system disorders Somnolence	16.4% 19/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	13.8% 16/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	7.8% 9/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Constipation	6.9% 8/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Dry Mouth	5.2% 6/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Infections and infestations Upper Respiratory Tract Infection	7.8% 9/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
General disorders Fatigue	8.6% 10/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
General disorders Pyrexia	6.0% 7/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	7.8% 9/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.
Psychiatric disorders Anxiety	5.2% 6/116 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study (up to 63 days post dose). Serious adverse events were collected for 30 days after the last dose of study drug.

Additional Information

Mila Etropolski, MD Clinical Leader

Johnson & Johnson Pharmaceutical Research & Development

Phone: 609-730-4537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60