Trial · NCT00420992

A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

NCT00420992, Phase 3, Completed, Pfizer; results first posted 2009-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee. Trials, record NCT00420992. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00420992

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
NCT number: NCT00420992
Status: Completed
Phases: Phase 3
Enrollment: 547 participants, actual
Lead sponsor: Pfizer
Conditions: Osteoarthritis, Chronic Pain
Interventions: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release), Placebo
First posted: 2007-01-11
Last updated: 2013-09-20
Results first posted: 2009-10-30

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)	randomization to 12 weeks following randomization	Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)	randomization to 12 weeks following randomization	intent to treat (ITT)	units on scale	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)	ALO-01		-0.2	Standard Deviation 1.94	units on scale
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)	Placebo		0.3	Standard Deviation 2.05	units on scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Titration Phase	STARTED	ALO-01	547
Titration Phase	STARTED	Placebo	0
Titration Phase	COMPLETED	ALO-01	344
Titration Phase	COMPLETED	Placebo	0
Titration Phase	NOT COMPLETED	ALO-01	203
Titration Phase	NOT COMPLETED	Placebo	0
Maintenance Phase	STARTED	ALO-01	171
Maintenance Phase	STARTED	Placebo	173
Maintenance Phase	COMPLETED	ALO-01	110
Maintenance Phase	COMPLETED	Placebo	98

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events69

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	ALO-01	12	171
other	Constipation	Gastrointestinal disorders	Placebo	7	173
other	Constipation	Gastrointestinal disorders	Titration ALO-01	167	547
other	Diarrhoea	Gastrointestinal disorders	ALO-01	21	171
other	Diarrhoea	Gastrointestinal disorders	Placebo	21	173
other	Diarrhoea	Gastrointestinal disorders	Titration ALO-01	15	547
other	Nausea	Gastrointestinal disorders	ALO-01	20	171
other	Nausea	Gastrointestinal disorders	Placebo	13	173
other	Nausea	Gastrointestinal disorders	Titration ALO-01	115	547
other	Dry mouth	Gastrointestinal disorders	ALO-01	3	171

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALO-01
Total, all-cause mortality	Placebo
Total, all-cause mortality	Titration ALO-01
Total, other adverse events	ALO-01	54	171
Total, other adverse events	Placebo	48	173
Total, other adverse events	Titration ALO-01	301	547
Total, serious adverse events	ALO-01	6	171
Total, serious adverse events	Placebo	3	173
Total, serious adverse events	Titration ALO-01	3	547

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26695349	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00420992

GET https://conductscience.org/api/trials/v1/NCT00420992/events?page=2

API reference For AI assistants