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CompletedNCT02279641Updated Dec 20, 2017Results posted

RDEA3170 and Allopurinol Combination Study in Gout Subjects

A Phase 1 interventional study of RDEA3170 10 mg and allopurinol 300 mg in Gout, sponsored by Ardea Biosciences, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-20.

Sponsored by Ardea Biosciences, Inc. (part of AstraZeneca) · Phase 1, Interventional, and Basic science

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Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 16 studies testing allopurinol in Gout — 1 open to participants now, 1 under way, none of them phase 3. Allopurinol · Gout.

Enrollment
15th of 16
12 · median 46
Started
2014
the only one that year
Phase 1
2 of 16
none open now
Registered
9th of 16
by date
Lead sponsor
5 of 16
Ardea Biosciences, Inc.

Among the 16 studies testing allopurinol in Gout, this one is the 15th largest by enrollment, is the only one that started in 2014, is one of 2 in phase 1, and was the 9th registered.

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

Browse Gout studies →

Open to participants now

1 of the 16 studies testing allopurinol in Gout is open now. Recruiting first, the newest first:

About allopurinol

Allopurinol: first FDA approval 1966 (ZYLOPRIM), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.

This study: 18 Years to 75 Years · male · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies testing allopurinol in Gout, or all of them as a file.
02

Study summary

This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.

03

Conditions studied

  • Gout

Browse trials for

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
  • Subject has a body weight ≥ 50 kg (110 lbs.) and a ≥ 18 and ≤ 45 kg/m2.
  • Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
  • Subject is free of any disease or medical condition, per the Investigator's judgment.

Exclusion criteria

Exclusion Criteria:

  • Subject is unable to take colchicine for gout flare prophylaxis.
  • Subject has a history or suspicion of kidney stones.
  • Subject has an estimated \< 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
  • Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
  • Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
  • Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Sequence A

    RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd

    Drug: RDEA3170 10 mg · Drug: allopurinol 300 mg

  • Experimental
    Sequence B

    allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd

    Drug: RDEA3170 10 mg · Drug: allopurinol 300 mg

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

    Time frame: 22 days

  2. Time of Occurrence of Maximum Observed Concentration (Tmax)

    Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

    Time frame: 22 days

  3. Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

    AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

    Time frame: 22 days

  4. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

    AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

    Time frame: 22 days

  5. Apparent Terminal Half-life (t1/2)

    t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

    Time frame: 22 days

  6. Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)

    Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

    Time frame: 22 days

  7. Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)

    CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

    Time frame: 22 days

  8. Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine

    Time frame: 22 days

  9. Maximum Observed Plasma Concentration (Cmax)

    Cmax of RDEA3170 Alone and In Combination with Allopurinol

    Time frame: 22 days

  10. Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

    AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol

    Time frame: 22 days

  11. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

    AUC last of RDEA3170 Alone and In Combination with Allopurinol

    Time frame: 22 days

  12. Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)

    Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol

    Time frame: 22 days

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 22 days

07

Results

Posted Dec 20, 2017

Participant flow

12 subjects were randomized

Participant flow — Overall Study
MilestoneRDEA3170 or Allopurinol Alone and in Combination (Sequence A)RDEA3170 or Allopurinol Alone and in Combination (Sequence B)
Started66
Completed66
Not completed00

Outcome measures

PrimaryMaximum Observed Plasma Concentration (Cmax)

Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

Time frame:
22 days
Reported as:
Geometric mean · μg/mL
Maximum Observed Plasma Concentration (Cmax)
μg/mLAllopurinol: Allopurinol AloneAllopurinol: RDEA3170 + AllopurinolOxypurinol: Allopurinol AloneOxypurinol: RDEA3170 + Allopurinol
Maximum Observed Plasma Concentration (Cmax)1.13 (0.894 to 1.43)1.51 (1.24 to 1.82)12.8 (11.7 to 14.0)8.68 (7.99 to 9.43)
Statistical analysis
  • Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 133 · 90% CI 111 to 159Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 67.9 · 90% CI 65.2 to 70.7Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryTime of Occurrence of Maximum Observed Concentration (Tmax)

Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

Time frame:
22 days
Reported as:
Median · hr
Time of Occurrence of Maximum Observed Concentration (Tmax)
hrAllopurinol: Allopurinol AloneAllopurinol: RDEA3170 + AllopurinolOxypurinol: Allopurinol AloneOxypurinol: RDEA3170 + AllopurinolRDEA3170: RDEA3170 AloneRDEA3170: RDEA3170 + Allopurinol
Time of Occurrence of Maximum Observed Concentration (Tmax)1.50 (1.00 to 4.00)1.25 (0.500 to 4.00)4.00 (1.50 to 6.00)3.50 (1.50 to 8.00)3.00 (1.50 to 4.00)3.00 (2.00 to 10.0)
PrimaryArea Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

Time frame:
22 days
Reported as:
Geometric mean · μg·hr/mL
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
μg·hr/mLAllopurinol: Allopurinol AloneAllopurinol: RDEA3170 + AllopurinolOxypurinol: Allopurinol AloneOxypurinol: RDEA3170 + AllopurinolRDEA3170: RDEA3170 + Allopurinol
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)3.69 (3.24 to 4.21)3.68 (3.28 to 4.13)255 (229 to 284)157 (140 to 177)115 (96.5 to 137)
Statistical analysis
  • Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 102 · 90% CI 93.3 to 111Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 61.8 · 90% CI 58.1 to 65.7Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • RDEA3170: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 95.9 · 90% CI 88.4 to 104Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryArea Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

Time frame:
22 days
Reported as:
Geometric mean · μg·hr/mL
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
μg·hr/mLAllopurinol: Allopurinol AloneAllopurinol: RDEA3170 + AllopurinolOxypurinol: Allopurinol AloneOxypurinol: RDEA3170 + Allopurinol
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)3.50 (3.04 to 4.04)3.61 (3.22 to 4.05)255 (229 to 284)157 (140 to 177)
Statistical analysis
  • Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 103 · 90% CI 94.9 to 112Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 61.8 · 90% CI 58.1 to 65.7Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryApparent Terminal Half-life (t1/2)

t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

Time frame:
22 days
Reported as:
Geometric mean · hr
Apparent Terminal Half-life (t1/2)
hrAllopurinol: Allopurinol AloneAllopurinol: RDEA3170 + AllopurinolOxypurinol: Allopurinol AloneOxypurinol: RDEA3170 + AllopurinolRDEA3170: RDEA3170 AloneRDEA3170: RDEA3170 + Allopurinol
Apparent Terminal Half-life (t1/2)1.06 (0.969 to 1.15)0.992 (0.890 to 1.10)43.2 (36.1 to 51.7)29.1 (23.9 to 35.4)11.5 (8.43 to 15.6)12.5 (8.99 to 17.4)
PrimaryAmount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)

Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

Time frame:
22 days
Reported as:
Geometric mean · mg
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
mgAllopurinol: Allopurinol AloneAllopurinol: RDEA3170 + AllopurinolOxypurinol: Allopurinol AloneOxypurinol: RDEA3170 + Allopurinol
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)25.4 (22.1 to 29.2)22.7 (19.2 to 26.9)231 (216 to 248)275 (262 to 290)
Statistical analysis
  • Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 89.5 · 90% CI 81.8 to 98.0Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 119 · 90% CI 114 to 125Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryRenal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)

CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

Time frame:
22 days
Reported as:
Geometric mean · mL/min
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
mL/minAllopurinol: Allopurinol AloneAllopurinol: RDEA3170 + AllopurinolOxypurinol: Allopurinol AloneOxypurinol: RDEA3170 + AllopurinolRDEA3170: RDEA3170 AloneRDEA3170: RDEA3170 + Allopurinol
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)120 (106 to 135)103 (87.1 to 122)15.1 (13.0 to 17.6)29.2 (25.1 to 33.9)9.28 (7.43 to 11.6)9.75 (7.73 to 12.3)
Statistical analysis
  • Allopurinol: Allopurinol Alone vs Allopurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 87.5 · 90% CI 79.3 to 96.6Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Oxypurinol: Allopurinol Alone vs Oxypurinol: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 193 · 90% CI 177 to 210Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • RDEA3170: RDEA3170 Alone vs RDEA3170: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 105 · 90% CI 94.4 to 117Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryPharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Time frame:
22 days
Reported as:
Mean · Percentage (%)
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Percentage (%)RDEA3170: RDEA3170 AloneOxypurinol: RDEA3170 + AllopurinolAllopurinol: Allopurinol Alone
Serum Urate Maximum % Change-50.5 ± 2.43-65.2 ± 1.57-43.0 ± 1.57
Urine Uric Acid % Change (0-24h)9.88 ± 7.61-21.6 ± 5.58-47.4 ± 2.67
Renal Clearance of Uric Acid % Change (0-24h)122 ± 46.8125 ± 42.2-8.50 ± 6.04
Fract. Excretion of Uric Acid % Change (0-24h)77.4 ± 18.078.4 ± 21.9-12.0 ± 5.46
SecondaryIncidence of Treatment-Emergent Adverse Events
Time frame:
22 days
Reported as:
Number · Number of participants
Incidence of Treatment-Emergent Adverse Events
Number of participantsRDEA3170: RDEA3170 AloneOxypurinol: RDEA3170 + AllopurinolAllopurinol: Allopurinol Alone
Incidence of Treatment-Emergent Adverse Events2 ± 2.431 ± 1.573 ± 1.57
PrimaryMaximum Observed Plasma Concentration (Cmax)

Cmax of RDEA3170 Alone and In Combination with Allopurinol

Time frame:
22 days
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Concentration (Cmax)
ng/mLRDEA3170: RDEA3170 AloneRDEA3170: RDEA3170 + Allopurinol
Maximum Observed Plasma Concentration (Cmax)14.6 (12.2 to 17.5)14.5 (11.7 to 17.9)
Statistical analysis
  • RDEA3170: RDEA3170 Alone vs RDEA3170: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 98.7 · 95% CI 87.7 to 111Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryArea Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol

Time frame:
22 days
Reported as:
Geometric mean · μg*hr/mL
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
μg*hr/mLRDEA3170: RDEA3170 AloneRDEA3170: RDEA3170 + Allopurinol
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)120 (98.1 to 147)115 (96.5 to 137)
Statistical analysis
  • RDEA3170: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 95.9 · 95% CI 88.4 to 104Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryArea Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

AUC last of RDEA3170 Alone and In Combination with Allopurinol

Time frame:
22 days
Reported as:
Geometric mean · ng·hr/mL
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
ng·hr/mLRDEA3170: RDEA3170 AloneRDEA3170: RDEA3170 + Allopurinol
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)120 (98.1 to 147)115 (96.5 to 137)
Statistical analysis
  • RDEA3170: RDEA3170 Alone vs RDEA3170: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 95.9 · 95% CI 88.4 to 104Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
PrimaryAmount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)

Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol

Time frame:
22 days
Reported as:
Geometric mean · ug
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
ugRDEA3170: RDEA3170 AloneRDEA3170: RDEA3170 + Allopurinol
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)66.8 (51.8 to 86.1)67.2 (51.7 to 87.4)
Statistical analysis
  • RDEA3170: RDEA3170 Alone vs RDEA3170: RDEA3170 + Allopurinol · Mixed Models Analysis · Geometric least squares mean ratio (%): 101 · 95% CI 86.7 to 117Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.

Adverse events

Collected over 22 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RDEA3170 10 mg qd—0/12 (0%)2/12 (16.7%)
RDEA3170 10 mg qd + Allopurinol 300 mg qd—0/12 (0%)1/12 (8.3%)
Allopurinol 300 mg qd—0/12 (0%)3/12 (25%)
Most frequent other events
Most frequent other events
EventRDEA3170 10 mg qdRDEA3170 10 mg qd + Allopurinol 300 mg qdAllopurinol 300 mg qd
DiarrhoeaGastrointestinal disorders1/120/120/12
ToothacheGastrointestinal disorders0/121/120/12
VomitingGastrointestinal disorders1/120/120/12
GastroenteritisInfections and infestations0/120/121/12
NasopharyngitisInfections and infestations1/120/120/12
DizzinessNervous system disorders1/120/120/12
HeadacheNervous system disorders0/120/121/12
PetechiaeSkin and subcutaneous tissue disorders0/121/120/12
RashSkin and subcutaneous tissue disorders0/120/121/12
ArthralgiaMusculoskeletal and connective tissue disorders1/120/120/12

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Sequence ASequence BTotal
Mean53 ± 10.149 ± 10.451 ± 10.0
Age, Customized
Age, Customized(Participants)Sequence ASequence BTotal
<656612
>=65000
Sex: Female, Male
Sex: Female, Male(Participants)Sequence ASequence BTotal
Female000
Male6612
Region of Enrollment
Region of Enrollment(Participants)Sequence ASequence BTotal
United States6612
08

Study locations

1 site
  • Overland Park, Kansas 66212, United States
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2014 to primary completion in Apr 2015, 5 months.

Results were first posted in Dec 2017, 2 years 8 months after primary completion.

Of 37 industry-sponsored phase 1 interventional studies under Gout, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's 5 months is below that.

Counting every sponsor, half of 40 studies reached it within 6 months; a quarter within 1 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2014
First posted
Oct 31, 2014
StartActual
Nov 1, 2014
Primary completionActual
Apr 6, 2015
CompletionActual
Sep 11, 2015
Results first posted
Dec 20, 2017
Last update
Dec 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02279641
Lead sponsor
Ardea Biosciences, Inc.
Responsible party
Sponsor
First posted
Oct 31, 2014
Start date
Nov 1, 2014
Primary completion
Apr 6, 2015
Completion
Sep 11, 2015
Results posted
Dec 20, 2017
Last update
Dec 20, 2017

Study contacts

J. Hall, MD
study director · Ardea Biosciences, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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