NCT00913627 is a Phase 2 clinical trial of ibuprofen in Pain, sponsored by Pfizer.

Who is sponsoring NCT00913627?

NCT00913627 is sponsored by Pfizer.

What drugs are being tested in NCT00913627?

Interventions in NCT00913627: ibuprofen, ibuprofen, naproxen, Placebo.

Is NCT00913627 still recruiting?

NCT00913627 is currently completed. Last updated 22 March 2018.

Are results published for NCT00913627?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-22 · How we verify

NCT00913627

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

Completed Phase 2 Results posted Last updated 22 March 2018

What this trial tests

Phase 2 trial testing ibuprofen in Pain in 196 participants. Completed in 5 August 2009.

Timeline

7 May 2009

Primary endpoint
1 August 2009

5 August 2009

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	196
Start date	7 May 2009
Primary completion	1 August 2009
Estimated completion	5 August 2009
Sites	1 location across United States

Drugs / interventions tested

ibuprofen (ibuprofen) — full drug profile →
ibuprofen (ibuprofen) — full drug profile →
naproxen (naproxen) — full drug profile →
Placebo

Conditions studied

Pain — all drugs for Pain →

Sponsor

Pfizer — full company profile →

Who can join

Adults 16 to 40, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) Primary · Baseline (0 hour) to 12 hours post dose

Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).

Group	Value	95% CI
Placebo	0.05	± 9.22
Ibuprofen IR/ER (Roller Compaction)	16.87	± 9.35
Ibuprofen IR/ER (Wet Granulation)	17.34	± 10.54
Naproxen	12.66	± 10.02

Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) Primary · 8 to 12 hours post dose

PID score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).

Group	Value	95% CI
Placebo	-0.03	± 4.05
Ibuprofen IR/ER (Roller Compaction)	6.57	± 4.44
Ibuprofen IR/ER (Wet Granulation)	7.14	± 5.24
Naproxen	5.14	± 5.02

Time to First Perceptible Pain Relief Secondary · Baseline to 6 hours

Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled "first perceptible relief", if the participant also depressed the second stopwatch labelled as "meaningful relief" by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels a

Group	Value	95% CI
Placebo	NA	NA – NA
Ibuprofen IR/ER (Roller Compaction)	29.4	23.3 – 35.3
Ibuprofen IR/ER (Wet Granulation)	29.4	26.1 – 36.2
Naproxen	32.1	29.5 – 58.0

Time to Treatment Failure Secondary · Baseline to 24 hours

Time to first rescue medication or discontinuation due to lack of efficacy

Group	Value	95% CI
Placebo	1.7	1.7 – 2.2
Ibuprofen IR/ER (Roller Compaction)	NA	NA – NA
Ibuprofen IR/ER (Wet Granulation)	NA	NA – NA
Naproxen	NA	NA – NA

Percentage of Participants With Treatment Failure Secondary · 8, 9, 10, 11, and 12 hours

Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy.

8 hours

Group	Value	95% CI
Placebo	82.8
Ibuprofen IR/ER (Roller Compaction)	11.3
Ibuprofen IR/ER (Wet Granulation)	12.5
Naproxen	24.1

9 hours

Group	Value	95% CI
Placebo	82.8
Ibuprofen IR/ER (Roller Compaction)	11.3
Ibuprofen IR/ER (Wet Granulation)	12.5
Naproxen	25.9

10 hours

Group	Value	95% CI
Placebo	82.8
Ibuprofen IR/ER (Roller Compaction)	17.0
Ibuprofen IR/ER (Wet Granulation)	12.5
Naproxen	27.6

11 hours

Group	Value	95% CI
Placebo	82.8
Ibuprofen IR/ER (Roller Compaction)	20.8
Ibuprofen IR/ER (Wet Granulation)	14.3
Naproxen	27.6

12 hours

Group	Value	95% CI
Placebo	82.8
Ibuprofen IR/ER (Roller Compaction)	20.8
Ibuprofen IR/ER (Wet Granulation)	17.9
Naproxen	32.8

Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8) Secondary · 0 to 4 hours and 4 to 8 hours

Time-weighted sum of PID score. PID based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).

SPID 0-4

Group	Value	95% CI
Placebo	-0.12	± 2.57
Ibuprofen IR/ER (Roller Compaction)	5.44	± 3.21
Ibuprofen IR/ER (Wet Granulation)	5.22	± 2.90
Naproxen	3.96	± 2.87

SPID 4-8

Group	Value	95% CI
Placebo	0.31	± 4.57
Ibuprofen IR/ER (Roller Compaction)	8.15	± 4.48
Ibuprofen IR/ER (Wet Granulation)	8.13	± 4.76
Naproxen	5.95	± 4.74

Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) Secondary · 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours

Time-weighted sum of PRID score where PRID=PID+PR. PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline, ranged from -1 to 3. Baseline pain intensity score of at least 2 required for enrollment. Higher positive PID values = improvement. PR: 5-point categorical pain relief scale None (0), A Little (1), Some (2), A Lot (3) or Complete (4). SPRID 0-4, SPRID 4-8, and SRID 8-12 scores ranged from -4 to 28, SPRID 0-12 ranged from -12 to 84, higher scores = greater improvement.

SPRID 0-4

Group	Value	95% CI
Placebo	1.78	± 5.45
Ibuprofen IR/ER (Roller Compaction)	15.48	± 6.60
Ibuprofen IR/ER (Wet Granulation)	15.12	± 6.10
Naproxen	11.97	± 6.51

SPRID 4-8

Group	Value	95% CI
Placebo	3.69	± 10.63
Ibuprofen IR/ER (Roller Compaction)	23.21	± 8.85
Ibuprofen IR/ER (Wet Granulation)	23.14	± 10.12
Naproxen	17.71	± 10.69

SPRID 8-12

Group	Value	95% CI
Placebo	3.00	± 9.38
Ibuprofen IR/ER (Roller Compaction)	19.36	± 9.94
Ibuprofen IR/ER (Wet Granulation)	20.73	± 11.43
Naproxen	15.86	± 11.56

SPRID 0-12

Group	Value	95% CI
Placebo	7.09	± 21.00
Ibuprofen IR/ER (Roller Compaction)	48.76	± 18.99
Ibuprofen IR/ER (Wet Granulation)	50.01	± 22.32
Naproxen	38.45	± 22.61

Time-weighted Sum of Pain Relief Scores (TOTPAR) Secondary · 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours

TOTPAR based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief). For time-weighted sum of pain relief scores from 0 to 4 hours (TOTPAR 0-4), from 4 to 8 hours (TOTPAR 4-8), and from 8 to 12 hours (TOTPAR 8-12): range of scores 0 (worst) to 16 (best). TOTPAR 0-12 range of scores 0 (worst) to 48 (best).

TOTPAR 0-4

Group	Value	95% CI
Placebo	1.91	± 3.25
Ibuprofen IR/ER (Roller Compaction)	10.04	± 3.66
Ibuprofen IR/ER (Wet Granulation)	9.90	± 3.51
Naproxen	8.01	± 3.96

TOTPAR 4-8

Group	Value	95% CI
Placebo	3.38	± 6.43
Ibuprofen IR/ER (Roller Compaction)	15.06	± 4.76
Ibuprofen IR/ER (Wet Granulation)	15.02	± 5.79
Naproxen	11.76	± 6.35

TOTPAR 8-12

Group	Value	95% CI
Placebo	3.03	± 5.75
Ibuprofen IR/ER (Roller Compaction)	12.79	± 5.97
Ibuprofen IR/ER (Wet Granulation)	13.59	± 6.61
Naproxen	10.72	± 6.89

TOTPAR 0-12

Group	Value	95% CI
Placebo	7.04	± 12.74
Ibuprofen IR/ER (Roller Compaction)	31.89	± 10.67
Ibuprofen IR/ER (Wet Granulation)	32.67	± 12.74
Naproxen	25.79	± 13.48

Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief Secondary · 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes

The elapsed time from dosing until the participant indicated first perceptible relief, provided the participant also indicated achieving meaningful relief. Perceptible relief defined as when participant first begins to feel any pain-relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she currently has now.

15 minutes

Group	Value	95% CI
Placebo	3.4
Ibuprofen IR/ER (Roller Compaction)	17.0
Ibuprofen IR/ER (Wet Granulation)	19.6
Naproxen	8.6

30 minutes

Group	Value	95% CI
Placebo	3.4
Ibuprofen IR/ER (Roller Compaction)	52.8
Ibuprofen IR/ER (Wet Granulation)	55.4
Naproxen	39.7

45 minutes

Group	Value	95% CI
Placebo	6.9
Ibuprofen IR/ER (Roller Compaction)	64.2
Ibuprofen IR/ER (Wet Granulation)	73.2
Naproxen	56.9

60 minutes

Group	Value	95% CI
Placebo	13.8
Ibuprofen IR/ER (Roller Compaction)	81.1
Ibuprofen IR/ER (Wet Granulation)	83.9
Naproxen	65.5

90 minutes

Group	Value	95% CI
Placebo	13.8
Ibuprofen IR/ER (Roller Compaction)	83.0
Ibuprofen IR/ER (Wet Granulation)	87.5
Naproxen	72.4

120 minutes

Group	Value	95% CI
Placebo	13.8
Ibuprofen IR/ER (Roller Compaction)	83.0
Ibuprofen IR/ER (Wet Granulation)	91.1
Naproxen	72.4

180 minutes

Group	Value	95% CI
Placebo	13.8
Ibuprofen IR/ER (Roller Compaction)	83.0
Ibuprofen IR/ER (Wet Granulation)	91.1
Naproxen	72.4

240 minutes

Group	Value	95% CI
Placebo	13.8
Ibuprofen IR/ER (Roller Compaction)	83.0
Ibuprofen IR/ER (Wet Granulation)	91.1
Naproxen	72.4

Time to Meaningful Pain Relief Secondary · Baseline to 6 hours

Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that is considered meaningful to the participant.

Group	Value	95% CI
Placebo	NA	NA – NA
Ibuprofen IR/ER (Roller Compaction)	59.7	52.3 – 88.3
Ibuprofen IR/ER (Wet Granulation)	76.7	56.5 – 99.3
Naproxen	84.1	63.8 – 174.2

Percentage of Participants Achieving Meaningful Pain Relief Secondary · 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes

Participants evaluated the time to first perceptible pain relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief defined as relief from the pain that is considered meaningful to the participant.

15 minutes

Group	Value	95% CI
Placebo	0.0
Ibuprofen IR/ER (Roller Compaction)	1.9
Ibuprofen IR/ER (Wet Granulation)	0.0
Naproxen	1.7

30 minutes

Group	Value	95% CI
Placebo	0.0
Ibuprofen IR/ER (Roller Compaction)	9.4
Ibuprofen IR/ER (Wet Granulation)	10.7
Naproxen	3.4

45 minutes

Group	Value	95% CI
Placebo	3.4
Ibuprofen IR/ER (Roller Compaction)	28.3
Ibuprofen IR/ER (Wet Granulation)	28.6
Naproxen	13.8

60 minutes

Group	Value	95% CI
Placebo	3.4
Ibuprofen IR/ER (Roller Compaction)	50.9
Ibuprofen IR/ER (Wet Granulation)	39.3
Naproxen	31.0

90 minutes

Group	Value	95% CI
Placebo	3.4
Ibuprofen IR/ER (Roller Compaction)	64.2
Ibuprofen IR/ER (Wet Granulation)	57.1
Naproxen	50.0

120 minutes

Group	Value	95% CI
Placebo	6.9
Ibuprofen IR/ER (Roller Compaction)	71.7
Ibuprofen IR/ER (Wet Granulation)	71.4
Naproxen	56.9

180 minutes

Group	Value	95% CI
Placebo	10.3
Ibuprofen IR/ER (Roller Compaction)	79.2
Ibuprofen IR/ER (Wet Granulation)	82.1
Naproxen	63.8

240 minutes

Group	Value	95% CI
Placebo	10.3
Ibuprofen IR/ER (Roller Compaction)	83.0
Ibuprofen IR/ER (Wet Granulation)	89.3
Naproxen	67.2

Participant Global Evaluation of Study Medication at 12 Hours Secondary · 12 hours

Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).

Very poor

Group	Value	95% CI
Placebo	20
Ibuprofen IR/ER (Roller Compaction)	2
Ibuprofen IR/ER (Wet Granulation)	2
Naproxen	7

Poor

Group	Value	95% CI
Placebo	4
Ibuprofen IR/ER (Roller Compaction)	1
Ibuprofen IR/ER (Wet Granulation)	0
Naproxen	1

Fair

Group	Value	95% CI
Placebo	1
Ibuprofen IR/ER (Roller Compaction)	3
Ibuprofen IR/ER (Wet Granulation)	4
Naproxen	8

Good

Group	Value	95% CI
Placebo	2
Ibuprofen IR/ER (Roller Compaction)	11
Ibuprofen IR/ER (Wet Granulation)	9
Naproxen	18

Very good

Group	Value	95% CI
Placebo	2
Ibuprofen IR/ER (Roller Compaction)	20
Ibuprofen IR/ER (Wet Granulation)	28
Naproxen	15

Excellent

Group	Value	95% CI
Placebo	0
Ibuprofen IR/ER (Roller Compaction)	16
Ibuprofen IR/ER (Wet Granulation)	13
Naproxen	9

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/29 (0%)

Deaths: —

Ibuprofen IR/ER (Roller Compaction)

Serious: 0/53 (0%)

Deaths: —

Ibuprofen IR/ER (Wet Granulation)

Serious: 0/56 (0%)

Deaths: —

Naproxen

Serious: 0/58 (0%)

Deaths: —

Other adverse events (17 terms — click to expand)

Reaction	System	Placebo	Ibuprofen IR/ER (Roller Co…	Ibuprofen IR/ER (Wet Granu…	Naproxen
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Eye swelling	Eye disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Feeling hot	General disorders	—	—	—	—
Malaise	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Epistaxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Cold sweat	Skin and subcutaneous tissue disorders	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Pallor	Vascular disorders	—	—	—	—

Data from ClinicalTrials.gov NCT00913627 adverse events section.

Sponsor's own description

The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Analgesic Efficacy of a New Immediate-Release/Extended-Release Formulation of Ibuprofen: Results From Single- and Multiple-Dose Postsurgical Dental Pain Studies.
Christensen S, Paluch E, Jayawardena S, Daniels S, et al · · 2017 · cited 11× · PMID 27545511 · DOI 10.1002/cpdd.297

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00913627 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 22 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00913627.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00913627

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of ibuprofen

Other recruiting trials for Pain

Other Pfizer trials

Verify against primary sources