Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety (NCT NCT00364533)

Last Updated: 2014-04-21

Results Overview

The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

367 participants

Primary outcome timeframe

48 hours

Results posted on

2014-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Tapentadol IR Fixed Dose 50 mg Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 75 mg Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 100 mg Tapentadol taken by mouth every 4-6 hours for 3 days	Oxycodone HCL IR Fixed Dose 10 mg oxycodone 10mg taken by mouth every 4-6 hours for 3 days	Placebo Fixed Dose Matching placebo taken by mouth every 4-6 hours for 3 days
Overall Study STARTED	77	71	75	67	75
Overall Study COMPLETED	35	31	30	36	24
Overall Study NOT COMPLETED	42	40	45	31	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Tapentadol IR Fixed Dose 50 mg Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 75 mg Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 100 mg Tapentadol taken by mouth every 4-6 hours for 3 days	Oxycodone HCL IR Fixed Dose 10 mg oxycodone 10mg taken by mouth every 4-6 hours for 3 days	Placebo Fixed Dose Matching placebo taken by mouth every 4-6 hours for 3 days
Overall Study Adverse Event	8	7	15	5	2
Overall Study Withdrawal by Subject	4	8	6	6	6
Overall Study Lack of Efficacy	22	22	21	17	42
Overall Study Subject discharged from hospital	4	1	2	3	1
Overall Study Variations in drug compliance	2	1	1	0	0
Overall Study Non-compliance	1	0	0	0	0
Overall Study Protocol Violation	1	1	0	0	0

Baseline Characteristics

A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tapentadol IR Fixed Dose 50 mg n=77 Participants Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 75 mg n=71 Participants Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 100 mg n=75 Participants Tapentadol taken by mouth every 4-6 hours for 3 days	Oxycodone HCL IR Fixed Dose 10 mg n=67 Participants oxycodone 10mg taken by mouth every 4-6 hours for 3 days	Placebo Fixed Dose n=75 Participants Matching placebo taken by mouth every 4-6 hours for 3 days	Total n=365 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 12.20 • n=99 Participants	62.8 years STANDARD_DEVIATION 9.24 • n=107 Participants	63.3 years STANDARD_DEVIATION 10.3 • n=206 Participants	61.3 years STANDARD_DEVIATION 12.39 • n=7 Participants	64.0 years STANDARD_DEVIATION 11.23 • n=31 Participants	62.7 years STANDARD_DEVIATION 11.11 • n=30 Participants
Sex: Female, Male Female	39 Participants n=99 Participants	32 Participants n=107 Participants	41 Participants n=206 Participants	41 Participants n=7 Participants	44 Participants n=31 Participants	197 Participants n=30 Participants
Sex: Female, Male Male	38 Participants n=99 Participants	39 Participants n=107 Participants	34 Participants n=206 Participants	26 Participants n=7 Participants	31 Participants n=31 Participants	168 Participants n=30 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Because the Sponsor terminated the study, the planned sample size was not reached in any treatment group, therefore, only a brief summary of an exploratory analysis of the primary efficacy variable (SPID48) is presented.

Outcome measures

Outcome measures
Measure	Tapentadol IR Fixed Dose 50 mg n=35 Participants Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 75 mg n=31 Participants Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 100 mg n=30 Participants Tapentadol taken by mouth every 4-6 hours for 3 days	Oxycodone HCL IR Fixed Dose 10 mg n=36 Participants oxycodone 10mg taken by mouth every 4-6 hours for 3 days	Placebo Fixed Dose n=24 Participants Matching placebo taken by mouth every 4-6 hours for 3 days
Sum of Pain Intensity Difference Over 48 Hours (SPID48)	73.9 score on a scale Standard Deviation 123.89	54.4 score on a scale Standard Deviation 128.22	49.3 score on a scale Standard Deviation 136.92	57.6 score on a scale Standard Deviation 125.73	-18.6 score on a scale Standard Deviation 130.74

SECONDARY outcome

Timeframe: 3 days

Population: Due to termination of trial, results were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days

Population: Due to termination of trial, results were not analyzed.

The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.

Outcome measures

Outcome data not reported

Adverse Events

Tapentadol IR Fixed Dose 50 mg

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Tapentadol IR Fixed Dose 75 mg

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Tapentadol IR Fixed Dose 100 mg

Serious events: 3 serious events

Other events: 53 other events

Deaths: 0 deaths

Oxycodone HCL IR Fixed Dose 10 mg

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo Fixed Dose

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tapentadol IR Fixed Dose 50 mg n=77 participants at risk Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 75 mg n=71 participants at risk Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 100 mg n=75 participants at risk Tapentadol taken by mouth every 4-6 hours for 3 days	Oxycodone HCL IR Fixed Dose 10 mg n=67 participants at risk oxycodone 10mg taken by mouth every 4-6 hours for 3 days	Placebo Fixed Dose n=75 participants at risk Matching placebo taken by mouth every 4-6 hours for 3 days
Cardiac disorders Atrial Fibrillation	0.00% 0/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.3% 1/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.3% 1/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Psychiatric disorders Confusional State	0.00% 0/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.5% 1/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Vascular disorders Deep Vein Thrombosis	1.3% 1/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Ileus	0.00% 0/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.4% 1/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Nervous system disorders Lethargy	0.00% 0/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.3% 1/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.3% 1/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Cardiac disorders Supraventricular Tachycardia	1.3% 1/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.

Other adverse events

Other adverse events
Measure	Tapentadol IR Fixed Dose 50 mg n=77 participants at risk Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 75 mg n=71 participants at risk Tapentadol taken by mouth every 4-6 hours for 3 days	Tapentadol IR Fixed Dose 100 mg n=75 participants at risk Tapentadol taken by mouth every 4-6 hours for 3 days	Oxycodone HCL IR Fixed Dose 10 mg n=67 participants at risk oxycodone 10mg taken by mouth every 4-6 hours for 3 days	Placebo Fixed Dose n=75 participants at risk Matching placebo taken by mouth every 4-6 hours for 3 days
Blood and lymphatic system disorders Anaemia	7.8% 6/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	4.2% 3/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	10.7% 8/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	16.4% 11/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	9.3% 7/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Investigations Body Temperature Increased	10.4% 8/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	9.9% 7/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	5.3% 4/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	7.5% 5/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	9.3% 7/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Psychiatric disorders Confusional State	7.8% 6/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	5.6% 4/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	14.7% 11/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.5% 1/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Constipation	14.3% 11/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	8.5% 6/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	13.3% 10/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	17.9% 12/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	9.3% 7/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Nervous system disorders Dizziness	9.1% 7/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	11.3% 8/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	21.3% 16/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	20.9% 14/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	5.3% 4/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Dry Mouth	1.3% 1/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	9.9% 7/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	4.0% 3/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	4.5% 3/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Psychiatric disorders Hallucination, Visual	2.6% 2/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	7.0% 5/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	10.7% 8/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	3.0% 2/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	2.7% 2/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Nervous system disorders Headache	6.5% 5/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	7.0% 5/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	2.7% 2/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	13.4% 9/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	17.3% 13/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Vascular disorders Hypotension	5.2% 4/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.4% 1/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	6.7% 5/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.5% 1/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	2.7% 2/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Psychiatric disorders Insomnia	1.3% 1/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	4.2% 3/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.3% 1/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	4.5% 3/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	5.3% 4/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	2.6% 2/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	5.6% 4/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.5% 1/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.3% 1/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	24.7% 19/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	7.0% 5/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	16.0% 12/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	17.9% 12/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	14.7% 11/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	3.9% 3/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	2.8% 2/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	5.3% 4/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	6.0% 4/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	0.00% 0/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
General disorders Pyrexia	19.5% 15/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	11.3% 8/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	17.3% 13/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	20.9% 14/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	9.3% 7/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Nervous system disorders Somnolence	14.3% 11/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	14.1% 10/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	22.7% 17/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	9.0% 6/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	1.3% 1/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	6.5% 5/77 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	8.5% 6/71 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	5.3% 4/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	14.9% 10/67 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.	16.0% 12/75 • All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.

Additional Information

Senior Director, Clinical Leader

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

Phone: 609-730-6780

Results disclosure agreements

Principal investigator is a sponsor employee A provision provides for 60 day prior review by sponsor extendable by 60 days to file a patent application and prior written consent of sponsor for disclosure of confidential information, if any.
Publication restrictions are in place

Restriction type: OTHER