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Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep

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ClinicalTrials.gov Identifier: NCT01073930
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : September 11, 2012
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Bowel Preparation
Interventions Drug: PicoPrep
Drug: HalfLytely
Drug: bisacodyl
Enrollment 608
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Period Title: Overall Study
Started 307 301
Safety Population (Treated) 305 298
Intent to Treat Population 304 [1] 297 [1]
Completed 304 295
Not Completed 3 6
Reason Not Completed
Withdrawal by Subject             3             2
Lost to Follow-up             0             1
Adverse Event             0             1
Noncompliance with study drug             0             1
Inadequate prep; unable to do procedure             0             1
[1]
One treated participant did not have an efficacy assessment performed.
Arm/Group Title PICOPREP HalfLytely Total
Hide Arm/Group Description “Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. Total of all reporting groups
Overall Number of Baseline Participants 305 298 603
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants 298 participants 603 participants
54.8  (10.04) 55.7  (10.00) 55.2  (10.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 298 participants 603 participants
Female
181
  59.3%
174
  58.4%
355
  58.9%
Male
124
  40.7%
124
  41.6%
248
  41.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 298 participants 603 participants
Hispanic or Latino
7
   2.3%
5
   1.7%
12
   2.0%
Not Hispanic or Latino
298
  97.7%
293
  98.3%
591
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 305 participants 298 participants 603 participants
American Indian or Alaska Native 1 1 2
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 36 27 63
White 265 268 533
Other 3 0 3
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 305 participants 298 participants 603 participants
29.4  (5.68) 29.6  (6.34) 29.5  (6.01)
1.Primary Outcome
Title Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
Hide Description Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 304 297
Measure Type: Number
Unit of Measure: percentage of participants
84.2 74.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was >-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was >0%.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.8
Confidence Interval (1-Sided) 97.5%
3.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Hide Description Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 304 297
Measure Type: Number
Unit of Measure: percentage of participants
Ascending colon 89.5 78.8
Mid colon 92.4 85.9
Recto-sigmoid colon 92.4 87.2
Overall: ascending, mid, and recto-sigmoid colon 86.8 75.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments Ascending colon comparison
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.7
Confidence Interval (1-Sided) 97.5%
4.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments Mid colon comparison
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.6
Confidence Interval (1-Sided) 97.5%
1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments Recto-sigmoid colon comparison
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.2
Confidence Interval (1-Sided) 97.5%
0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments Overall: Ascending, mid, and recto-sigmoid colon comparison
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 11.4
Confidence Interval (1-Sided) 97.5%
5.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
Hide Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 302 296
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 57.9 8.1
Easy 31.5 20.9
Tolerable 9.6 47.0
Difficult 1.0 14.9
Very difficult 0 9.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
Hide Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Two participants either did not complete the questionnaire or did not answer this question.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 303 296
Measure Type: Number
Unit of Measure: percentage of participants
Yes 99.0 89.9
No 1.0 10.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Hide Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 301 296
Measure Type: Number
Unit of Measure: percentage of participants
Excellent 46.8 16.6
Good 45.2 42.9
Fair 6.6 28.7
Poor 1.0 7.1
Bad 0.3 4.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Hide Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. One participant either did not complete the questionnaire or did not answer this question.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 303 297
Measure Type: Number
Unit of Measure: percentage of participants
Excellent 23.4 2.7
Good 50.5 18.9
Tolerable 25.7 56.2
Poor 0.3 13.1
Bad 0 9.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?
Hide Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 302 296
Measure Type: Number
Unit of Measure: percentage of participants
Yes 96.0 54.7
No 4.0 45.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?
Hide Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 301 296
Measure Type: Number
Unit of Measure: percentage of participants
Yes 1.7 13.5
No 98.3 86.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PICOPREP, HalfLytely
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.
Time Frame up to one month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants who were treated.
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description:
“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Overall Number of Participants Analyzed 305 298
Measure Type: Number
Unit of Measure: participants
Any TEAE 211 217
Death 0 0
Serious AE 1 2
TEAEs leading to discontinuation of study drug 0 1
Severe TEAEs 2 6
Related TEAEs 19 26
Time Frame Treatment-emergent AEs occurring from Day 1 up to one month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PICOPREP HalfLytely
Hide Arm/Group Description “Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
All-Cause Mortality
PICOPREP HalfLytely
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PICOPREP HalfLytely
Affected / at Risk (%) Affected / at Risk (%)
Total   1/305 (0.33%)   2/298 (0.67%) 
Gastrointestinal disorders     
Pancreatitis acute  1  1/305 (0.33%)  0/298 (0.00%) 
General disorders     
Non-cardiac chest pain  1  0/305 (0.00%)  1/298 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  0/305 (0.00%)  1/298 (0.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PICOPREP HalfLytely
Affected / at Risk (%) Affected / at Risk (%)
Total   166/305 (54.43%)   177/298 (59.40%) 
Gastrointestinal disorders     
Colonic polyp  1  52/305 (17.05%)  51/298 (17.11%) 
Diverticulum  1  60/305 (19.67%)  72/298 (24.16%) 
Diverticulum intestinal  1  11/305 (3.61%)  16/298 (5.37%) 
Haemorrhoids  1  54/305 (17.70%)  59/298 (19.80%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon adenoma  1  56/305 (18.36%)  51/298 (17.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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 only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01073930     History of Changes
Other Study ID Numbers: 2009-01
First Submitted: February 22, 2010
First Posted: February 23, 2010
Results First Submitted: August 10, 2012
Results First Posted: September 11, 2012
Last Update Posted: February 12, 2013