Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.

NCT00711529 | Completed Phase 3 Results DMC

• 1 other identifier: 08-0057
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or chemotherapy are at risk for experiencing premature menopause because of their treatment. The resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's quality of life. Treatment for menopausal symptoms with the gold standard of hormone replacement therapy is not done routinely as it is unclear whether it can increase risk of tumor recurrence. In addition, many medical oncologists feel it is contraindicated in this population, especially among women whose breast cancers have estrogen receptors. This has lead to an increased interest in options other than estrogen replacement in the treatment of hot flashes, though most investigations of alternative medications have shown a suboptimal response. Recent studies have suggested that non-drug treatments using alternative or complementary therapies may be effective. Specifically, hypnosis has been promoted as a means to control hot flashes, though it has not been tested in a randomized fashion. In accordance with the National Cancer Institute's recent initiatives to expand the goals of clinical trials to include symptom management studies, our purpose is to evaluate the role of complementary and alternative therapies for improvement of symptoms in women with breast cancer. Specifically, we plan to evaluate the use of hypnotherapy for the treatment of therapy-induced hot flashes in breast cancer survivors. We intend to recruit 60 women into a pilot feasibility trial comparing hypnotherapy to the drug gabapentin (Neurontin®) for the treatment of therapy-induced hot flashes in eligible women who are receiving care at the Breast Health Center. We have chosen gabapentin based on recent studies showing it may be an effective non-estrogen treatment for this indication. We will identify patients who are experiencing at least one daily hot flash as a result of the treatment they received for their breast cancer for participation. When enrolled, they will be randomized into either the treatment arm, in which they will receive daily gabapentin, or the experimental arm, in which they will undergo weekly hypnotherapy. Our study hypothesis is that hypnotherapy will be more effective than gabapentin in the control of hot flashes in this population.

Conditions

Breast Cancer; Hot Flashes

Keywords

hot flashes; breast cancer; Hypnotherapy; Quality of Life; Gabapentin

Outcome Measures

Primary Outcomes (6)

• Number of Daily Hot Flashes

  Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.

  Baseline

• Number of Daily Hot Flashes

  Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark.

  Week 4

• Number of Daily Hot Flashes

  Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark.

  Week 8

• Hot Flash Severity Score

  The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.

  Baseline

• Hot Flash Severity Score

  The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.

  Week 4

• Hot Flash Severity Score

  The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.

  Week 8

Secondary Outcomes (3)

• Hot Flash Related Daily Interference Score (HFRDIS)

  Baseline

• Hot Flash Related Daily Interference Score (HFRDIS)

  Week 4

• Hot Flash Related Daily Interference Score (HFRDIS)

  Week 8

Study Arms (2)

Hypnotherapy

EXPERIMENTAL

Patients randomized to the experimental arm were scheduled for three one-hour inductions by a single hypnotherapist, each one week apart. Standardized outlines were used for each induction. The second and third sessions also began with a standardized induction, followed by the establishment of an "anchor," or physical reference point (forefinger to thumb), used to invoke images of coolness, which were individualized according to patient preference. Patients were also instructed by the same hypnotherapist in self-hypnosis and guided imagery techniques to be used at home with the assistance of standardized audio compact disks. Participation lasted eight weeks.

Behavioral: Hypnotherapy

Gabapentin

ACTIVE COMPARATOR

Patients randomized to the gabapentin arm were prescribed 900mg of the drug daily (300 mg by mouth three times daily).

Drug: gabapentin

Interventions

Hypnotherapy BEHAVIORAL

Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. surveys. The therapist will be prohibited from asking subjects about clinical responses to the hypnosis sessions. The patients will also be instructed on self-hypnosis techniques to be used at home.

Also known as: hypnosis, mind-body therapy

Hypnotherapy

gabapentin DRUG

Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily). This dose has been shown to be more effective than 300mg daily. Larger doses have not been evaluated in this population, and may be associated with a more significant side-effect profile. The prescription for gabapentin will be provided at the patient's enrollment appointment. The patients will take gabapentin as prescribed daily for the study-enrollment period, which is 8 weeks.

Also known as: Neurontin, gabarone

Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with histologic confirmation of a diagnosis of infiltrating carcinoma of the breast are eligible for participation.
• Women with non-invasive or pre-invasive lesions of the breast, including but not limited to ductal carcinoma in situ (DCIS), atypical ductal hyperplasia (ADH) or lobular carcinoma in situ (LCIS) are eligible for participation.
• Women with a known breast cancer susceptibility gene (eg, BRCA) mutation or strong family history of breast cancer are eligible.
• Any woman age 60 years or more who cannot take estrogen therapy because of a real or perceived risk of developing breast cancer are eligible.
• Women under the age of 60 with a Gail model score of 1.6% or more are eligible.
• Subjective report of at least one daily hot flash.
• Able to provide voluntary informed consent.
• Karnofsky performance status \> 70%.
• Women with a history of breast cancer must have undergone treatment with curative intent.
• ≥ 4 weeks from completion of chemotherapy or radiation therapy, where appropriate.
• adequate hematopoietic function (ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL)
• adequate renal and hepatic function \[Bilirubin ≤ 1.5 times upper limit of normal (ULN), serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5x ULN, Alkaline phosphatase ≤ 2.5x ULN, and Creatinine ≤ 2x ULN\].
• No clinical evidence of disease (complete remission).
• Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated.
• Patients receiving hormonal therapy in lieu of or following chemotherapy will be eligible to participate.

You may not qualify if:

• History or active secondary cancer within the last 5 years (except for superficial basal cell skin cancers).
• Any residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematological toxicity.
• Unable to give informed consent or unable to adhere to protocol.
• Any serious medical or psychiatric illness likely to interfere with participation in this clinical study, concurrent uncontrolled illness, or ongoing or active infection will be excluded.
• Any history of alcohol or drug abuse.
• Allergy to gabapentin.
• History of seizure disorder.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Breast Health Center, Program in Women's Oncology, Women & Infants' Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (33)

• Goldhirsch A, Gelber RD, Castiglione M. The magnitude of endocrine effects of adjuvant chemotherapy for premenopausal breast cancer patients. The International Breast Cancer Study Group. Ann Oncol. 1990;1(3):183-8. doi: 10.1093/oxfordjournals.annonc.a057718.

  PMID: 2261364 BACKGROUND

• Anderson WF, Jatoi I, Devesa SS. Distinct breast cancer incidence and prognostic patterns in the NCI's SEER program: suggesting a possible link between etiology and outcome. Breast Cancer Res Treat. 2005 Mar;90(2):127-37. doi: 10.1007/s10549-004-3777-3.

  PMID: 15803359 BACKGROUND

• Bines J, Oleske DM, Cobleigh MA. Ovarian function in premenopausal women treated with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1996 May;14(5):1718-29. doi: 10.1200/JCO.1996.14.5.1718.

  PMID: 8622093 BACKGROUND

• Del Mastro L, Venturini M, Sertoli MR, Rosso R. Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications. Breast Cancer Res Treat. 1997 Apr;43(2):183-90. doi: 10.1023/a:1005792830054.

  PMID: 9131274 BACKGROUND

• Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44. doi: 10.1200/JCO.1995.13.11.2737.

  PMID: 7595732 BACKGROUND

• Jonat W, Kaufmann M, Sauerbrei W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes JC, de Matteis A, Stewart A, Eiermann W, Szakolczai I, Palmer M, Schumacher M, Geberth M, Lisboa B; Zoladex Early Breast Cancer Research Association Study. Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: The Zoladex Early Breast Cancer Research Association Study. J Clin Oncol. 2002 Dec 15;20(24):4628-35. doi: 10.1200/JCO.2002.05.042.

  PMID: 12488406 BACKGROUND

• International Breast Cancer Study Group (IBCSG); Castiglione-Gertsch M, O'Neill A, Price KN, Goldhirsch A, Coates AS, Colleoni M, Nasi ML, Bonetti M, Gelber RD. Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial. J Natl Cancer Inst. 2003 Dec 17;95(24):1833-46. doi: 10.1093/jnci/djg119.

  PMID: 14679153 BACKGROUND

• Northouse LL. Breast cancer in younger women: effects on interpersonal and family relations. J Natl Cancer Inst Monogr. 1994;(16):183-90.

  PMID: 7999463 BACKGROUND

• Ganz PA, Rowland JH, Desmond K, Meyerowitz BE, Wyatt GE. Life after breast cancer: understanding women's health-related quality of life and sexual functioning. J Clin Oncol. 1998 Feb;16(2):501-14. doi: 10.1200/JCO.1998.16.2.501.

  PMID: 9469334 BACKGROUND

• Ganz PA, Greendale GA, Petersen L, Kahn B, Bower JE. Breast cancer in younger women: reproductive and late health effects of treatment. J Clin Oncol. 2003 Nov 15;21(22):4184-93. doi: 10.1200/JCO.2003.04.196.

  PMID: 14615446 BACKGROUND

• Avis NE, Crawford S, Manuel J. Quality of life among younger women with breast cancer. J Clin Oncol. 2005 May 20;23(15):3322-30. doi: 10.1200/JCO.2005.05.130.

  PMID: 15908646 BACKGROUND

• Carpenter JS, Andrykowski MA, Cordova M, Cunningham L, Studts J, McGrath P, Kenady D, Sloan D, Munn R. Hot flashes in postmenopausal women treated for breast carcinoma: prevalence, severity, correlates, management, and relation to quality of life. Cancer. 1998 May 1;82(9):1682-91.

  PMID: 9576289 BACKGROUND

• Loprinzi CL, Kugler JW, Sloan JA, Mailliard JA, LaVasseur BI, Barton DL, Novotny PJ, Dakhil SR, Rodger K, Rummans TA, Christensen BJ. Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial. Lancet. 2000 Dec 16;356(9247):2059-63. doi: 10.1016/S0140-6736(00)03403-6.

  PMID: 11145492 BACKGROUND

• Carpenter JS, Storniolo AM, Johns S, Monahan PO, Azzouz F, Elam JL, Johnson CS, Shelton RC. Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist. 2007 Jan;12(1):124-35. doi: 10.1634/theoncologist.12-1-124.

  PMID: 17227907 BACKGROUND

• Jin Y, Desta Z, Stearns V, Ward B, Ho H, Lee KH, Skaar T, Storniolo AM, Li L, Araba A, Blanchard R, Nguyen A, Ullmer L, Hayden J, Lemler S, Weinshilboum RM, Rae JM, Hayes DF, Flockhart DA. CYP2D6 genotype, antidepressant use, and tamoxifen metabolism during adjuvant breast cancer treatment. J Natl Cancer Inst. 2005 Jan 5;97(1):30-9. doi: 10.1093/jnci/dji005.

  PMID: 15632378 BACKGROUND

• Reddy SY, Warner H, Guttuso T Jr, Messing S, DiGrazio W, Thornburg L, Guzick DS. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):41-8. doi: 10.1097/01.AOG.0000222383.43913.ed.

  PMID: 16816054 BACKGROUND

• Loprinzi CL, Kugler JW, Barton DL, Dueck AC, Tschetter LK, Nelimark RA, Balcueva EP, Burger KN, Novotny PJ, Carlson MD, Duane SF, Corso SW, Johnson DB, Jaslowski AJ. Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5. J Clin Oncol. 2007 Jan 20;25(3):308-12. doi: 10.1200/JCO.2006.07.5390. Epub 2006 Dec 4.

  PMID: 17146104 BACKGROUND

• Pandya KJ, Thummala AR, Griggs JJ, Rosenblatt JD, Sahasrabudhe DM, Guttuso TJ, Morrow GR, Roscoe JA. Pilot study using gabapentin for tamoxifen-induced hot flashes in women with breast cancer. Breast Cancer Res Treat. 2004 Jan;83(1):87-9. doi: 10.1023/B:BREA.0000010676.54597.22.

  PMID: 14997058 BACKGROUND

• Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005 Sep 3-9;366(9488):818-24. doi: 10.1016/S0140-6736(05)67215-7.

  PMID: 16139656 BACKGROUND

• Elkins G, Marcus J, Stearns V, Hasan Rajab M. Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors. Psychooncology. 2007 May;16(5):487-92. doi: 10.1002/pon.1096.

  PMID: 17048223 BACKGROUND

• Elkins G, Marcus J, Palamara L, Stearns V. Can hypnosis reduce hot flashes in breast cancer survivors? A literature review. Am J Clin Hypn. 2004 Jul;47(1):29-42. doi: 10.1080/00029157.2004.10401473.

  PMID: 15376607 BACKGROUND

• Younus J, Simpson I, Collins A, Wang X. Mind control of menopause. Womens Health Issues. 2003 Mar-Apr;13(2):74-8. doi: 10.1016/s1049-3867(02)00196-2.

  PMID: 12732444 BACKGROUND

• Buettner C, Kroenke CH, Phillips RS, Davis RB, Eisenberg DM, Holmes MD. Correlates of use of different types of complementary and alternative medicine by breast cancer survivors in the nurses' health study. Breast Cancer Res Treat. 2006 Nov;100(2):219-27. doi: 10.1007/s10549-006-9239-3. Epub 2006 Jul 5.

  PMID: 16821087 BACKGROUND

• Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.

  PMID: 6646795 BACKGROUND

• Hann DM, Jacobsen PB, Azzarello LM, Martin SC, Curran SL, Fields KK, Greenberg H, Lyman G. Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory. Qual Life Res. 1998 May;7(4):301-10. doi: 10.1023/a:1024929829627.

  PMID: 9610214 BACKGROUND

• Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.

  PMID: 11738160 BACKGROUND

• Groenvold M, Klee MC, Sprangers MA, Aaronson NK. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol. 1997 Apr;50(4):441-50. doi: 10.1016/s0895-4356(96)00428-3.

  PMID: 9179103 BACKGROUND

• Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139.

  PMID: 9440735 BACKGROUND

• Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.

  PMID: 8874337 BACKGROUND

• Hedeker D, Mermelstein RJ. Application of random-effects regression models in relapse research. Addiction. 1996 Dec;91 Suppl:S211-29.

  PMID: 8997794 BACKGROUND

• Hedeker D, Gibbons RD. MIXREG: a computer program for mixed-effects regression analysis with autocorrelated errors. Comput Methods Programs Biomed. 1996 May;49(3):229-52. doi: 10.1016/0169-2607(96)01723-3.

  PMID: 8800609 BACKGROUND

• Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90. doi: 10.1200/JCO.2001.19.23.4280.

  PMID: 11731510 BACKGROUND

• Maclaughlan David S, Salzillo S, Bowe P, Scuncio S, Malit B, Raker C, Gass JS, Granai CO, Dizon DS. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study. BMJ Open. 2013 Sep 10;3(9):e003138. doi: 10.1136/bmjopen-2013-003138.

  PMID: 24022390 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Interventions

Hypnosis; Mind-Body Therapies; Gabapentin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

We were unable to meet recruitment goals because of 1) lower-than-anticipated rate of referrals, and 2) subjects' unwillingness to randomization. This resulted in small numbers that limit interpretation of results.

Results Point of Contact

• Title: Shannon MacLaughlan, MD
• Organization: Stanford Hospital

smaclaug@stanford.edu

650-724-0456

Study Officials

• Shannon D MacLaughlan, MD

  Women & Infants' Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Don S Dizon, MD

  Women & Infants' Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shannon MacLaughlan, M.D.

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 24, 2013
• Results First Posted: June 24, 2013

Record last verified: 2013-05

Locations

US (1)