Pain, PostoperativePhase 3NCT01929031

Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain

A Phase 3 study testing ibuprofen + caffeine, ibuprofen and caffeine in people with Pain, Postoperative and Tooth Diseases, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Pain, Postoperative, Tooth Diseases
What is being tested?: ibuprofen + caffeine, ibuprofen and caffeine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 562 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Mar 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Males and females 18 to 55 years of age;
Outpatients scheduled to undergo surgical extraction of 3-4 impacted third molar(s), with a minimum of two mandibular extractions. The two mandibular third molars may be partial bony impactions or full bony impactions (as long as the trauma rating is not severe and the surgeons do not feel the subject will have extreme post-surgical pain) OR there may be a combination of one full bony impaction with the second mandibular being a soft tissue impaction or partial bony impaction. Maxillary third molars (or supernumerary teeth) of any type can be extracted;
Use of only the following preoperative medication(s)/ anesthetic(s): topical benzocaine, short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide;
Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;
Examined by the attending oral surgeon or physician and medically cleared to participate in the study;
Scheduled to undergo a qualifying surgical procedure;
In good general health, with a BMI of 30 or less, and have no contraindications to any of the study medications or anesthetic drugs;
Subjects have at least a categorical pain score of moderate and a numerical rating scale (NRS) score of 5 or greater within 4.5 hours from the time of the last suture.

Who cannot join

Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, hyper- or hypothyroidism);
Use of a prescription or non-prescription drug with which the administration of ibuprofen or any other non steroidal anti inflammatory or caffeine is contraindicated;
Acute local infection at the time of surgery that could confound the post-surgical evaluation;
Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, intravaginal or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test;
Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic ulcer disease;
History of alcoholism or substance abuse within the last year, or is currently abusing alcohol or other mood-altering drugs (e.g., cannabis). Subjects who are taking central nervous system or other psychotropic drugs (including St. Johns Wort, or any other nutritional supplement known to have psychotropic effects) may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled;

Show all 18Show fewer

Habituation to analgesic drugs or caffeine (i.e., routine use of oral analgesics 5 or more times per week or ingestion of 4 or more caffeine-containing drinks daily); use of "high energy" drinks more than once per week;
Use of any type of systemic corticosteroid within the past 30 days or a history of current or previous use of anabolic steroids;
History of allergic reaction (e.g., asthma, rhinitis, swelling, shock, or hives) to acetaminophen, ibuprofen, naproxen, aspirin, celecoxib, or any other non steroidal anti inflammatory or caffeine;
Prior use of any type of analgesic or non steroidal anti inflammatory within 5 half-lives of that drug before surgery, except for pre-anesthetic medication and anesthesia for the procedure;
Ingestion of any caffeine-containing beverages, chocolate, or alcohol 6 hours or less before surgery;
Has impaired liver function, e.g., serum Alanine transaminase, aspartate aminotransferase, alkaline phosphatase, or Gamma-glutamyltransferase greater than 2.5 times the upper limit of normal, or blood urea nitrogen, creatinine, or bilirubin greater than 1.5 times the upper limit of normal without a known benign explanation;
Has known history of a positive HIV antibody test or known HIV infection;
Has a known history of Hepatitis B or C;
Has a clinically significant abnormal electrocardiogram (ECG) at screening as determined by the Investigator:
Has taken an investigational product within the past 30 days;
Has previously been entered into this study;
The subject is a member of the study site staff either directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study or Sponsor.

Trial locations and contacts

1 site in 1 country.

United States1 site

1335.1.202 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah

Other trials in United States

About this study

Official title: A Single-centre, Double-blind, Randomised, Two-stage, Parallel-group Study to Assess the Efficacy and Safety of the Fixed Dose Combination of Ibuprofen 400 mg and Caffeine 100 mg Versus Ibuprofen 400 mg, Caffeine 100 mg and Placebo in Patients With Postoperative Dental Pain

Conditions: Pain, Postoperative, Tooth Diseases
Being tested: ibuprofen + caffeine, ibuprofen, caffeine, placebo
Medical subject headings: Pain, Postoperative, Tooth Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ibuprofen + caffeineDrug
FDC tablet
ibuprofenDrug
tablet.
ibuprofenDrug
tablet
caffeineDrug
tablet
ibuprofen + caffeineDrug
Fixed Dose Combination (FDC) tablet
placeboDrug
tablet
placeboDrug
tablet
caffeineDrug
tablet
ibuprofenDrug
tablet
ibuprofen + caffeineDrug
FDC tablet

Study groups in NCT01929031
Study group	Role	What they receive
Caffeine-Ibuprofen	Other	Study Stage 1: One Caffeine 100 mg tablet after dental surgery; Arm Type: Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one ibuprofen 400 mg tablet, while awake, over 5 days; Arm Type: Active Comparator Receives: Drug: ibuprofen; Drug: caffeine
Placebo-Ibuprofen/Caffeine	Other	Study Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine tablet, while awake, over 5 days; Arm Type: Experimental Receives: Drug: ibuprofen + caffeine; Drug: placebo
Ibuprofen/Caffeine-Ibuprofen/Caffeine	Other	Study Stage 1: One Ibuprofen 400 mg/Caffeine 100 mg tablet after dental surgery: Arm Type Experimental - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type Experimental Receives: Drug: ibuprofen + caffeine
Ibuprofen-Ibuprofen	Other	Study Stage 1: One Ibuprofen 400 mg tablet after dental surgery; Arm Type Active Comparator - Study Stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake, over 5 days; Arm type; Active Comparator Receives: Drug: ibuprofen
Caffeine-Ibuprofen/Caffeine	Other	Study Stage 1: One Caffeine 100 mg tablet after dental surgery. Arm Type; Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type: Experimental Receives: Drug: caffeine; Drug: ibuprofen + caffeine
Placebo-Ibuprofen	Other	Study Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake over 5 days; Arm Type: Active Comparator Receives: Drug: placebo; Drug: ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h)
SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 8 were considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 8 hours.
Measured: 0 to 8 hours

Secondary outcomes (3)

Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h)
SPRID0-2h: Time-weighted sum of PAR and PID from 0 to 2 hours, score range: -10 (worst) to 28 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5 and 2 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 2 was considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 2 hours.
Measured: 0 to 2 hours
Duration of Pain Relief
Duration of pain relief was defined as the time between the administration of first dose of trial medication and first dose of rescue medication or second dose of trial medication, whichever was first. Duration of pain relief was censored at 8 hours.
Measured: 8 hours
Time to Meaningful Pain Relief
Time to meaningful pain relief was captured by a stopwatch, which was started by the study staff immediately after the administration of the first dose of trial medication and which was to be stopped by the patient as soon as he/she felt meaningful pain relief. Time to meaningful pain relief was censored at 8 hours.
Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Mar 2014

First posted27 Aug 2013 (estimated)
Study startAug 2013
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 562 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01929031
Sponsor's protocol ID: 1335.1
Status last verified: Sep 2016
First submitted: 22 Aug 2013
Last updated: 16 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Forderreuther S, Lampert A, Hitier S, Lange R, Weiser T. The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial. Adv Ther. 2020 Jun;37(6):2976-2987. doi: 10.1007/s12325-020-01297-y. Epub 2020 Apr 24.
PubMed 32333328
Weiser T, Richter E, Hegewisch A, Muse DD, Lange R. Efficacy and safety of a fixed-dose combination of ibuprofen and caffeine in the management of moderate to severe dental pain after third molar extraction. Eur J Pain. 2018 Jan;22(1):28-38. doi: 10.1002/ejp.1068. Epub 2017 Aug 14.
PubMed 28805281

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-centre, Double-blind, Randomised, Two-stage, Parallel-group Study to Assess the Efficacy and Safety of the Fixed Dose Combination of Ibuprofen 400 mg and Caffeine 100 mg Versus Ibuprofen 400 mg, Caffeine 100 mg and Placebo in Patients With Postoperative Dental Pain
ClinicalTrials.gov ID: NCT01929031
Acronym / sponsor ID: 1335.1
Conditions: Pain, Postoperative, Tooth Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 562 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 27 Aug 2013 (estimated)
Results: Posted 16 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Caffeine-Ibuprofen	Other	Drug: ibuprofen, Drug: caffeineStudy Stage 1: One Caffeine 100 mg tablet after dental surgery; Arm Type: Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one ibuprofen 400 mg tablet, while awake, over 5 days; Arm Type: Active Comparator
Placebo-Ibuprofen/Caffeine	Other	Drug: ibuprofen + caffeine, Drug: placeboStudy Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine tablet, while awake, over 5 days; Arm Type: Experimental
Ibuprofen/Caffeine-Ibuprofen/Caffeine	Other	Drug: ibuprofen + caffeineStudy Stage 1: One Ibuprofen 400 mg/Caffeine 100 mg tablet after dental surgery: Arm Type Experimental - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type Experimental
Ibuprofen-Ibuprofen	Other	Drug: ibuprofenStudy Stage 1: One Ibuprofen 400 mg tablet after dental surgery; Arm Type Active Comparator - Study Stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake, over 5 days; Arm type; Active Comparator
Caffeine-Ibuprofen/Caffeine	Other	Drug: caffeine, Drug: ibuprofen + caffeineStudy Stage 1: One Caffeine 100 mg tablet after dental surgery. Arm Type; Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type: Experimental
Placebo-Ibuprofen	Other	Drug: placebo, Drug: ibuprofenStudy Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake over 5 days; Arm Type: Active Comparator

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Males and females 18 to 55 years of age;
Outpatients scheduled to undergo surgical extraction of 3-4 impacted third molar(s), with a minimum of two mandibular extractions. The two mandibular third molars may be partial bony impactions or full bony impactions (as long as the trauma rating is not severe and the surgeons do not feel the subject will have extreme post-surgical pain) OR there may be a combination of one full bony impaction with the second mandibular being a soft tissue impaction or partial bony impaction. Maxillary third molars (or supernumerary teeth) of any type can be extracted;
Use of only the following preoperative medication(s)/ anesthetic(s): topical benzocaine, short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide;
Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;
Examined by the attending oral surgeon or physician and medically cleared to participate in the study;

Key exclusion criteria (18 listed)

Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, hyper- or hypothyroidism);
Use of a prescription or non-prescription drug with which the administration of ibuprofen or any other non steroidal anti inflammatory or caffeine is contraindicated;
Acute local infection at the time of surgery that could confound the post-surgical evaluation;
Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, intravaginal or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test;
Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic ulcer disease;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ibuprofen + caffeineFDC tablet	Drug	Placebo-Ibuprofen/Caffeine
ibuprofentablet.	Drug	Ibuprofen-Ibuprofen
ibuprofentablet	Drug	Caffeine-Ibuprofen
caffeinetablet	Drug	Caffeine-Ibuprofen/Caffeine
ibuprofen + caffeineFixed Dose Combination (FDC) tablet	Drug	Ibuprofen/Caffeine-Ibuprofen/Caffeine
placebotablet	Drug	Placebo-Ibuprofen
placebotablet	Drug	Placebo-Ibuprofen/Caffeine
caffeinetablet	Drug	Caffeine-Ibuprofen
ibuprofentablet	Drug	Placebo-Ibuprofen
ibuprofen + caffeineFDC tablet	Drug	Caffeine-Ibuprofen/Caffeine

Primary outcome

Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h)
Time frame: 0 to 8 hours
SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 8 were considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 8 hours.

3 secondary outcomes

Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h)
Time frame: 0 to 2 hours
Duration of Pain Relief
Time frame: 8 hours
Time to Meaningful Pain Relief
Time frame: 8 hours

Results and safety

Results posted to the registry on 16 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ibuprofen/Caffeine - Ibuprofen/Caffeine	213	209
Ibuprofen - Ibuprofen	209	207
Caffeine - Ibuprofen/Caffeine	35	34
Caffeine - Ibuprofen	35	35
Placebo - Ibuprofen/Caffeine	34	33
Placebo - Ibuprofen	36	35

Primary outcome: Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h)

Time frame: 0 to 8 hours. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 70	Caffeine n = 70	Ibuprofen n = 209	Ibuprofen/Caffeine n = 213
Value	10.554 (3.527)	15.824 (3.525)	40.165 (2.047)	52.291 (2.027)

Placebo vs Ibuprofen/Caffeine: Mean Difference (Final Values): 41.738 (95% CI 33.767 to 49.708), p <0.0001, ANCOVA
Caffeine vs Ibuprofen/Caffeine: Mean Difference (Final Values): 36.467 (95% CI 28.497 to 44.437), p <0.0001, ANCOVA
Ibuprofen vs Ibuprofen/Caffeine: Mean Difference (Final Values): 12.126 (95% CI 6.493 to 17.759), p <0.0001, ANCOVA

Population analysed: Randomized patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of study drug date/time until drug discontinuation date + 24 hours (inclusive). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 70 (0%)	3 of 70 (4.3%)	Not reported
Caffeine	0 of 70 (0%)	1 of 70 (1.4%)	Not reported
Ibuprofen	1 of 279 (0.4%)	9 of 279 (3.2%)	Not reported
Ibuprofen/Caffeine	0 of 282 (0%)	23 of 282 (8.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32333328Forderreuther S, Lampert A, Hitier S, Lange R, Weiser T. The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial. Adv Ther. 2020 Jun;37(6):2976-2987. doi: 10.1007/s12325-020-01297-y. Epub 2020 Apr 24.
Derived from this study: PubMed 28805281Weiser T, Richter E, Hegewisch A, Muse DD, Lange R. Efficacy and safety of a fixed-dose combination of ibuprofen and caffeine in the management of moderate to severe dental pain after third molar extraction. Eur J Pain. 2018 Jan;22(1):28-38. doi: 10.1002/ejp.1068. Epub 2017 Aug 14.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ibuprofen + caffeine, ibuprofen and caffeine in people with Pain, Postoperative and Tooth Diseases, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) (time frame: 0 to 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01929031, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.