Trial Outcomes & Findings for Study of Pain Control in Hemorrhoidectomy (NCT NCT00890721)

Last Updated: 2013-08-06

Results Overview

To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond to the following question: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

189 participants

Primary outcome timeframe

72 hours

Results posted on

2013-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	SKY0402 During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.	Placebo During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Overall Study STARTED	95	94
Overall Study COMPLETED	94	93
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Pain Control in Hemorrhoidectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SKY0402 n=95 Participants During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.	Placebo n=94 Participants During the hemorrhoidectomy, 30cc Placebo injected into the wound.	Total n=189 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	86 Participants n=5 Participants	86 Participants n=7 Participants	172 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age Continuous	48 years STANDARD_DEVIATION 12.2 • n=5 Participants	48.7 years STANDARD_DEVIATION 12 • n=7 Participants	48.4 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	27 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	67 Participants n=7 Participants	130 Participants n=5 Participants
Region of Enrollment Poland	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants
Region of Enrollment Serbia	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Georgia	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Outcome measures

Outcome measures
Measure	SKY0402 n=94 Participants During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.	Placebo n=93 Participants During the hemorrhoidectomy, 30cc Placebo injected into the wound.
The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo.	141.8 units on a scale*hr Standard Error 10.7	202.5 units on a scale*hr Standard Error 10.7

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

Adverse Events

SKY0402

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SKY0402 n=94 participants at risk During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.	Placebo n=93 participants at risk During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Vascular disorders Thrombophlebitis	0.00% 0/94	1.1% 1/93 • Number of events 1

Other adverse events

Other adverse events
Measure	SKY0402 n=94 participants at risk During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.	Placebo n=93 participants at risk During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Gastrointestinal disorders Painful defaecation	2.1% 2/94	5.4% 5/93

Additional Information

Executive Medical Director

Pacira Pharmaceuticals, Inc.

Phone: 203-837-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place