A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy

This study has been completed.

Study NCT00609466 Information provided by Grünenthal GmbH

First Received on January 24, 2008. Last Updated on November 10, 2011 History of Changes

Results First Received: September 16, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Bunionectomy Pain Postoperative Pain Acute Pain
Interventions:	Drug: CG5503 IR Drug: Morphine Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period for this in-patient, multicenter study occurred between 04 September 2007 and 11 December 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial consisted of a Screening Period (Day -28 up to the first surgical incision on Day -1), a Surgical Period (Day -1 to Day 1 at approximately 03:00 h.), a Qualification Period (Day 1), a Double-Blind Treatment Period (Day 1 up to Day 4), and a Follow-up Period (Day 8 up to Day 18).

Reporting Groups

	Description
CG5503	CG5503 IR 75mg 4-6 hourly
Morphine	Morphine IR 30mg 4 to 6 hourly
Placebo	Matching Placebo 4 to 6 hourly

Participant Flow: Overall Study

	CG5503	Morphine	Placebo
STARTED	96	96	99
COMPLETED	94	90	95
NOT COMPLETED	2	6	4
Withdrawal by Subject	0	1	1
Adverse Event	2	3	1
Lack of Efficacy	0	2	2

Baseline Characteristics

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Reporting Groups

	Description
CG5503	CG5503 IR 75mg 4-6 hourly
Morphine	Morphine IR 30mg 4 to 6 hourly
Placebo	Matching Placebo 4 to 6 hourly

Baseline Measures

	CG5503	Morphine	Placebo	Total
Number of Participants [units: participants]	96	96	99	291
Age [units: participants]
<=18 years	0	1	1	2
Between 18 and 65 years	94	88	90	272
>=65 years	2	7	8	17
Age [units: years] Mean ± Standard Deviation	44.6 ± 12.58	43.7 ± 14.19	43.8 ± 13.93	44.0 ± 13.55
Gender [units: participants]
Female	83	73	88	244
Male	13	23	11	47
Region of Enrollment [units: participants]
United States	96	96	99	291

Outcome Measures

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1. Primary:

Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. [ Time Frame: Baseline value to 48 hours after first study drug intake. ]

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2. Secondary:

Number of Participants Using Rescue Medication [ Time Frame: Baseline up to 72 hours after first study drug intake ]

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3. Secondary:

Total Pain Relief (TOTPAR) [ Time Frame: Baseline to 48 hours after first study drug intake ]

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4. Secondary:

Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity [ Time Frame: Baseline to 6 hours after intake of first study drug ]

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5. Secondary:

Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity [ Time Frame: Baseline to 12 hours after first study drug intake ]

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6. Secondary:

Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity [ Time Frame: Baseline to 24 hours after first study drug intake ]

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7. Secondary:

Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity [ Time Frame: Baseline to 72 hours after first intake of study drug ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Grünenthal GmbH reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither Grünenthal nor the investigator has the right to prohibit publication unless publication can be shown to affect possible patent rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lortab (hydrocodone/acetaminophen) was allowed as rescue medication.

Results Point of Contact:

Name/Title: René Allard
Organization: Grunenthal
phone: 49 241 569 3223
e-mail: Clinical-Trials@grunenthal.com

No publications provided

Responsible Party:	Grünenthal GmbH
ClinicalTrials.gov Identifier:	NCT00609466 History of Changes
Other Study ID Numbers:	574139
Study First Received:	January 24, 2008
Results First Received:	September 16, 2009
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration